Full-Time PV Physician II

Pharmacovigilance (PV) Physician II is responsible for:

1. Medical review of ICSRs and literature review
2. Writing signal detection reports
3. Supporting writing and/or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS)
4. Reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment, including:
   • Coding
   • Assessment of seriousness
   • Listedness/expectedness
   • Company causality
   • Writing of Company comment
   • Follow-up questions
   • Analysis of Similar Events (when required)
5. Completion of all required supporting documentation (trackers)
6. Supporting the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of safety issues
7. Reviewing and providing input in periodic reports
8. Reviewing literature screening search strategy
9. Reviewing articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings
10. Reviewing database outputs
11. Delegation to support signal detection activities upon acquiring sufficient experience
12. Proposing a course of action whenever a new risk is identified

Required Qualifications and Skills:

• Medically qualified physician with demonstrated experience in PharmacoVigilance
• Clinical setting experience
• Excellent interpersonal skills
• Ability to plan, organize, prioritize, and execute multiple tasks
• Ability to work effectively cross-culturally and cross-functionally, valuing teamwork
• Communication skills
• Presentation skills

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