About the Role
The Pharmacovigilance Physician position with PrimeVigilance offers an opportunity for Medical Doctors to start and develop your career in Drug Safety. PrimeVigilance’s Pharmacovigilance Physician team is based in North America, Europe and Asia.
Key Accountabilities
Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
Review includes coding, assessment of seriousness, expectedness, and causality
Writing of Company comment, follow-up questions and analysis of similar events
Completion of all required supporting documentation such as trackers
Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
Review and provide input in periodic reports
Review literature screening search strategy and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
Qualifications
MD Qualification
Ability to plan, organise, prioritise and execute multiple tasks
Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
Strong communication and presentation skills
Advanced English skills, both verbal and written, at least B2
Advanced knowledge of MS Office
Tech Stack
pharmacovigilancedrug safetymedical reviewadverse event assessmentcase safety reportsliterature reviewMS Office