Clinical research careers at August Research


We are always interested in hearing from motivated clinical research professionals who would like to join our team.

To inquire about careers with August Research, please send your CV and cover letter directly at careers@augustresearch.com.

Open positions:
Finance Associate in Bulgaria


August Research, An Everest Clinical Research Company, is looking for a Finance Associate to join our team in Bulgaria.

This is a hybrid, Sofia based position, for a candidate with at least 2 years of experience in finance and/or accounting area. The Finance Associate provides general financial support and oversight in their office and/or assigned country.

Job responsibilities will include:

  • Processing employees’ expenses reports: collecting and reviewing domestic and international business travel expenses from employees, ensuring compliance with Company-wide and country-specific travel policy, and/or project-related requirements
  • Processing local accounting documents: collecting monthly accounting documents (vendor invoices, travel expense reports. etc.), preparing and delivering to external accounting and payroll vendor, ensuring local reporting deadlines
  • Entering employee travel and office accounting documents into internal accounting software Preparing monthly reports with employee travel and other project-related billable costs (Pass-Through Costs) for the office and/or assigned country
  • Operating electronic banking: setting-up bank payments for management approval, ensuring payment deadlines
  • Preparing monthly/quarterly cash budget for their office and/or assigned country
  • Supports other functions: Office Administration, HR and Clinical Departments with administrative support, document preparation, oversight and management, as needed

  • Skills required:

  • University degree in relevant field: economics, accounting, finance
  • At least 2 years prior experience in finance and/or accounting area
  • Very good written and verbal English
  • Strong verbal and written communication skills
  • Organizational and time management aptitude
  • Computer competency, including MS Excel
  • Ability to operate standard office equipment
  • Ability to work as part of a team

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.
    Clinical Trial Drug Safety Associate in Bulgaria

    August Research, An Everest Clinical Research Company, is looking for a Clinical Trial Drug Safety Associate to join our PV team in Bulgaria. This is a hybrid, Sofia based position, for a candidate with at least two years' drug safety experience in a pharmaceutical or clinical research environment.

    Job responsibilities will include:

  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Perform training of study related materials related to case processing of individual case study reports (ICSRs) for a clinical trial, including the study protocol and Safety Management Plan (SMP).
  • Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.
  • Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.
  • Perform quality control (QC) review of case processing by other PV personnel.
    • Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary.
    • Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.
    • Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and is up-to-date, complete, and concise.
    • Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites.
    • Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus.
    • Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements.
  • May generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
  • May also perform a data entry role in ICSR case processing, including generation of the case narrative.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Review study-specific SMPs written by other PV personnel; occasionally draft SMPs.
  • Perform reconciliation of safety data between clinical and safety databases.
  • Perform UAT of safety database builds to ensure validation of the study and reporting configuration.
  • May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary.
  • Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences
  • At least two years' drug safety experience in a pharmaceutical or clinical research environment.
  • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
  • Experience with safety case processing of SAEs.
  • Experience with an accepted clinical data capture and management system (preferred).
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred).
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred).
  • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  • Detail-oriented, customer- and quality-focused.
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.
    Senior Clinical Trial Drug Safety Associate in Bulgaria


    August Research, An Everest Clinical Research Company, is looking for a Senior Clinical Trial Drug Safety Associate to join our PV team in Bulgaria. This is a hybrid, Sofia based position, for a candidate with 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.

    Job responsibilities will include:

  • Assume a leader/mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
  • Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects. The project information may include the study protocol, SMP, Case Report Forms, Investigator’s Brochure, etc.
  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members. Case processing includes, but is not limited to, the following:
    • Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports and redaction as necessary.
    • Entering case safety data into the safety database and generating queries for any critical or missing information.
    • Writing patient narratives for ongoing PV projects; includes review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete and concise.
    • Interacting with the Lead Data Manager to post queries to clinical database, where applicable, or directly with clinical study sites to obtain the missing case information.
    • Performing QC review of data in the safety database entered by another Safety Associate.
    • Interacting with the Everest Medical Monitor to produce high quality case narratives and regulatory report forms that conform to Everest’s standards and regulatory requirements.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms.
  • Participate in UAT including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents.
  • Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
  • Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
  • Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study Trial Master File [TMF]).
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Contribute to the preparation and review of additional regulatory reporting documents (e.g., listings for IND/DSUR/Annual Reports), or other documents, as necessary.
  • Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows.
  • May provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Assist with new SOP development for PV procedures.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences
  • 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
  • Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. Global PV regulation experience is preferred.
  • Experience with safety case processing in clinical trials.
  • Prior experience with a safety database including case processing and generating reports/line listings from the database; Oracle Argus Safety database experience is preferred.
  • Familiar with E2B (XML) format for safety reporting to regulatory agencies.
  • Ability to work independently with little supervision; self-motivated and productive.
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • Detail-oriented, customer-
  • Senior Clinical Trial Drug Safety Associate in Poland


    August Research, An Everest Clinical Research Company, is looking for a Senior Clinical Trial Drug Safety Associate to join our team in Poland. This is a hybrid, Warsaw based position, for a candidate with 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.

    Job responsibilities will include:

  • Assume a leader/mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
  • Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects. The project information may include the study protocol, SMP, Case Report Forms, Investigator’s Brochure, etc.
  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members. Case processing includes, but is not limited to, the following:
    • Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports and redaction as necessary.
    • Entering case safety data into the safety database and generating queries for any critical or missing information.
    • Writing patient narratives for ongoing PV projects; includes review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete and concise.
    • Interacting with the Lead Data Manager to post queries to clinical database, where applicable, or directly with clinical study sites to obtain the missing case information.
    • Performing QC review of data in the safety database entered by another Safety Associate.
    • Interacting with the Everest Medical Monitor to produce high quality case narratives and regulatory report forms that conform to Everest’s standards and regulatory requirements.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms.
  • Participate in UAT including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents.
  • Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
  • Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
  • Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study Trial Master File [TMF]).
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Contribute to the preparation and review of additional regulatory reporting documents (e.g., listings for IND/DSUR/Annual Reports), or other documents, as necessary.
  • Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows.
  • May provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Assist with new SOP development for PV procedures.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences.
  • 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
  • Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. Global PV regulation experience is preferred.
  • Experience with safety case processing in clinical trials.
  • Prior experience with a safety database including case processing and generating reports/line listings from the database; Oracle Argus Safety database experience is preferred.
  • Familiar with E2B (XML) format for safety reporting to regulatory agencies.
  • Ability to work independently with little supervision; self-motivated and productive.
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • Detail-oriented, customer- and quality-focused.
  • Strong attention to detail.
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.
  • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  • Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.
  • .

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.
    Clinical Trial Drug Safety Associate in Poland


    August Research, An Everest Clinical Research Company, is looking for a Clinical Trial Drug Safety Associate to join our team in Poland. This is a hybrid, Warsaw based position, for a candidate with at least two years' drug safety experience in a pharmaceutical or clinical research environment.

    Job responsibilities will include:

  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Perform training of study related materials related to case processing of individual case study reports (ICSRs) for a clinical trial, including the study protocol and Safety Management Plan (SMP).
  • Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.
  • Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.
  • Perform quality control (QC) review of case processing by other PV personnel.
    • Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary.
    • Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.
    • Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and is up-to-date, complete, and concise.
    • Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites.
    • Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus.
    • Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements.
  • May generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
  • May also perform a data entry role in ICSR case processing, including generation of the case narrative.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Review study-specific SMPs written by other PV personnel; occasionally draft SMPs.
  • Perform reconciliation of safety data between clinical and safety databases.
  • Perform UAT of safety database builds to ensure validation of the study and reporting configuration.
  • May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary.
  • Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences.
  • At least two years' drug safety experience in a pharmaceutical or clinical research environment.
  • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
  • Experience with safety case processing of SAEs.
  • Experience with an accepted clinical data capture and management system (preferred).
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred).
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred).
  • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  • Detail-oriented, customer- and quality-focused).
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.
    Clinical Trial Drug Safety Associate in Romania


    August Research, An Everest Clinical Research Company, is looking for a Clinical Trial Drug Safety Associate to join our team in Romania. This is a hybrid, Bucharest based position, for a candidate with at least two years' drug safety experience in a pharmaceutical or clinical research environment.

    Job responsibilities will include:

  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Perform training of study related materials related to case processing of individual case study reports (ICSRs) for a clinical trial, including the study protocol and Safety Management Plan (SMP).
  • Perform PV activities in a timely manner according to regulatory and sponsor reporting requirements.
  • Perform as the Lead Safety Associate for assigned trials, ensuring compliance with all PV requirements.
  • Perform quality control (QC) review of case processing by other PV personnel.
    • Review hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports to ensure that redaction of personal identifying information has occurred, as necessary.
    • Perform QC review of data in the safety database for cases entered by other PV personnel, ensuring data accurately reflects the relevant case details in the source documents.
    • Review the patient narrative, ensuring it adheres to the narrative template and accurately describes the case details and is up-to-date, complete, and concise.
    • Generate queries for any critical or missing information. Send queries to the Data Manager for posting to the clinical database and/or generate Data Clarification Forms (DCFs) and send queries directly to the study sites.
    • Ensure all case documentation is filed and saved appropriately, including uploading of source files into Argus.
    • Interact with the Everest Medical Monitor to ensure the high quality of case narratives and regulatory report forms and that they conform to Everest’s standards and regulatory requirements.
  • May generate regulatory report forms (MedWatch/CIOMS/E2B) for reportable events for clients’ submission to regulatory authorities and Investigators/Institutional Review Boards (IRBs).
  • May also perform a data entry role in ICSR case processing, including generation of the case narrative.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Review study-specific SMPs written by other PV personnel; occasionally draft SMPs.
  • Perform reconciliation of safety data between clinical and safety databases.
  • Perform UAT of safety database builds to ensure validation of the study and reporting configuration.
  • May contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), Line Listings, or other documents, as necessary.
  • Provide weekend/holiday coverage, on a rotating basis with other PV personnel, for case processing and management of cases requiring expedited reporting.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences.
  • At least two years' drug safety experience in a pharmaceutical or clinical research environment.
  • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
  • Experience with safety case processing of SAEs.
  • Experience with an accepted clinical data capture and management system (preferred).
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred).
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred).
  • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  • Detail-oriented, customer- and quality-focused).
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.
    Senior Clinical Trial Drug Safety Associate in Romania


    August Research, An Everest Clinical Research Company, is looking for a Senior Clinical Trial Drug Safety Associate to join our team in Romania. This is a hybrid, Bucharest based position, for a candidate with 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.

    Job responsibilities will include:

  • Assume a leader/mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
  • Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects. The project information may include the study protocol, SMP, Case Report Forms, Investigator’s Brochure, etc.
  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members. Case processing includes, but is not limited to, the following:
    • Review of hardcopy and/or electronic SAE/device incident/pregnancy report forms and supplementary reports and redaction as necessary.
    • Entering case safety data into the safety database and generating queries for any critical or missing information.
    • Writing patient narratives for ongoing PV projects; includes review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete and concise.
    • Interacting with the Lead Data Manager to post queries to clinical database, where applicable, or directly with clinical study sites to obtain the missing case information.
    • Performing QC review of data in the safety database entered by another Safety Associate.
    • Interacting with the Everest Medical Monitor to produce high quality case narratives and regulatory report forms that conform to Everest’s standards and regulatory requirements.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms.
  • Participate in UAT including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents.
  • Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
  • Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases.
  • Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study Trial Master File [TMF]).
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Contribute to the preparation and review of additional regulatory reporting documents (e.g., listings for IND/DSUR/Annual Reports), or other documents, as necessary.
  • Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows.
  • May provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients.
  • Keep current with industry best working practices in PV/MDV guidance(s) and regulations.
  • Assist with new SOP development for PV procedures.
  • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.

  • Skills required:

  • Bachelor or Master’s degree in Life Sciences
  • 4 years relevant work experience in Drug Safety/Pharmacovigilance in a pharmaceutical or CRO environment.
  • Comprehensive understanding of FDA, Health Canada, and/or EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. Global PV regulation experience is preferred.
  • Experience with safety case processing in clinical trials.
  • Prior experience with a safety database including case processing and generating reports/line listings from the database; Oracle Argus Safety database experience is preferred.
  • Familiar with E2B (XML) format for safety reporting to regulatory agencies.
  • Ability to work independently with little supervision; self-motivated and productive.
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • Detail-oriented, customer- and quality-focused.
  • Strong attention to detail.
  • Excellent interpersonal and teamwork skills.
  • Computing skills in MS Office applications.
  • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data.
  • Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions, is preferred.

  • Interested candidates should submit a CV and cover letter in English to careers@augustresearch.com

    The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.