CSRM Physician - Senior Principal Scientist, Drug Safety

Position Overview:

The CSRM Physician leads clinical risk management and safety surveillance for assigned investigational and marketed products. Chairs the Risk Management Safety Team (RMST) and leads development/maintenance of risk management and pharmacovigilance plans.

• Participate on Product Development Teams; chair the RMST and related sub-teams for assigned products.
• Partner with clinical development and Clinical Research to ensure safety-focused clinical programs and benefit-risk evaluations in aggregate safety reports.
• Coordinate with cross-functional teams (clinical development, epidemiology, regulatory affairs, statistics, manufacturing) to align safety activities with global PV/risk management strategies.
• Evaluate safety data from multiple sources (clinical trials, literature, post-approval use) and ensure completeness in CCDS.
• Provide scientific strategy for safety documents (CTD components, RMPs, Periodic Safety Update Reports) and ensure medical/scientific appropriateness of product circular safety sections.
• Lead safety surveillance (aggregate analysis, post-approval safety signaling reviews) using medical judgment; collaborate with CSRM Associate.
• Drive risk management actions: pharmacovigilance action recommendations, labeling recommendations, and development of RMPs, PV strategies, and risk minimization.
• Oversee review/approval of labeling files in the safety database; demonstrate MedDRA knowledge.
• Prepare safety summaries/analyses for regulatory filings; may supervise CSRM medical associates.

• Required:
  
  MD, DO, or equivalent
• Preferred:
  Board Certification

• 3+ years clinical experience post-graduate training (or relevant clinical experience)
• Prior drug development experience (clinical and/or regulatory)
• Experience in clinical safety, pharmacovigilance and/or risk management
• Organizational leadership; excellent communication, writing, and analytics

Clinical Risk Management, Clinical Safety, Data Analysis, Detail-Oriented, Drug Safety Surveillance, FDA Submissions, Patient Safety, Pharmacovigilance, Safety Reporting

• Oncology