Clinical research careers at August Research


Open positions:

Safety Scientist in Sofia, Bulgaria
August Research is searching for a Safety Scientist to support our growing PV Department in Sofia, Bulgaria.

We are looking to hire experienced Safety Scientist with 2 or more years of experience in Pharmacovigilance operations who is excited by the challenge of working in a small team environment, supporting safety reporting for ongoing clinical trials.

Job responsibilities will include:
  • Responsible for the receipt, data entry, follow up and submission of Serious Adverse Event (SAE) reports. The Safety Scientist will also participate with project start-up, process flows, database configuration, training and SOPs
  • Assists in the development of Safety Management Plans (SMPs)
  • Ensures adherence to SOPs and SMPs and assists in the identification of process improvements and document updates
  • Ensures adherence to the Scope of Work and informs management of deviations
  • Assists in all aspects of SAE reporting
  • Collects, processes and maintains required documents as per regulatory requirements
  • Enters SAE information into database, writes SAE narrative, ensures quality, ensures workflow timelines and regulatory reporting requirements for all appropriate countries
  • Maintains quality and accuracy of the data
  • Assists in the reconciliation of databases
  • Monitors compliance metrics and strives for continual improvement
  • Assists with the validation of systems
  • Assists in review of data and the generation of queries for additional information
  • Needs to work as a team to ensure quality and compliance with August Research, Sponsor and Regulatory expectations.

Skills required:
  • Previous experience in Pharmacovigilance operations
  • Working knowledge of Pharmacovigilance Regulations
  • Proficient with computer programs (safety database, Microsoft applications)
  • Excellent written and oral communication skills
  • Fluent in Medical terminology
  • Excellent organizational and time management skills
  • Fluent in written and verbal English
  • Ability to work well within a team
  • Computer competency
  • University degree in life sciences; Health Care Professional preferred.

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

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.