Senior Drug Safety Physician

• Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities.
• Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists on medical aspects of drug safety.

Review and provide medical, safety input on all required safety reports, including but not limited to:

• 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
• Author and review aggregate reports for medical context and consistency per client requirements and SOPs.
• Provide medical advice to case processors for authoring sections.
• Train and mentor new team members as required.
• Serve as a Subject Matter Expert (SME).
• Assist the Manager, DSP, with inspection readiness activities and audits.
• Provide inputs for process improvements.

Minimum Requirements

• Minimum 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