
Expert Medical Reviewer: Pharmacovigilance Specialist
2 days ago
As a Senior Drug Safety Physician, you will play a vital role in ensuring the safety of medications by conducting signal detection, analysis, evaluation, and ongoing surveillance activities. Your expertise will be instrumental in providing medical guidance to Drug Safety Associates (DSAs) and specialists on the medical aspects of drug safety.
">- Conduct thorough reviews of required safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Assessment Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit Risk Assessment, Signal Evaluation Reports (SERs), Clinical Overview (COs), Clinical Expert Statements, Investigator notification letters, and aggregate reports for medical context and consistency.
- Provide medical advice to case processors for authoring sections.
- Train and mentor new team members as required.
- Serve as a Subject Matter Expert (SME).
Minimum Requirements:
- At least 1 year of experience in safety scientific writing/PSUR/PBRER/Aggregate report/Signal evaluation.
- Proven ability to perform medical review and provide guidance on drug safety.
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