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