Full-Time Senior PV Physician I

Senior Pharmacovigilance (PV) Physician I is responsible for:

• Medical review of ICSRs and Serious Adverse Event (SAE) reports.
• Writing and/or reviewing signal detection reports and aggregate reports (DSURS, PSURS, PBRERs, PADERS).
• Reviewing Risk Management Plans (RMPs).
• Mentoring junior PV Physicians.
• Supporting the QPPV in medical aspects and safety issues.
• Reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness, Company causality, and writing of Company comment, follow-up questions, and Analysis of Similar Events (when required).
• Acting as a Qualified Person for Pharmacovigilance or supporting the Qualified Person in medical understanding and evaluation of safety issues.
• Reviewing and approving literature screening search strategy.
• Reviewing articles for ICSRs/SAEs and safety-related findings.
• Cooperating in preparation of and providing input in Risk Management Plans.
• Supporting/leading the preparation of responses to regulatory authority requests.
• Reviewing and providing input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports.
• Acting as Company Lead in a specific pharmacovigilance area.
• Participating in signal detection activities.
• Providing consultation to clients on benefit/risk assessment and risk minimization.
• Providing training and mentoring of junior PV Physicians.

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