CSRM Physician - Senior Principal Scientist, Drug Safety
Merck
September 03, 2026
Remote friendly (Upper Gwynedd, PA)
United States
Medical Affairs
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.
Primary Activities:
- 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.
Education:
- Required: MD, DO, or equivalent
- Preferred: Board Certification
Required Experience & Skills:
- 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
Required Skills:
Clinical Risk Management, Clinical Safety, Data Analysis, Detail-Oriented, Drug Safety Surveillance, FDA Submissions, Patient Safety, Pharmacovigilance, Safety Reporting
Preferred Skills:
- Oncology
Application:
- Apply via https://jobs.merck.com/us/en (application deadline listed on the posting).
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.
Primary Activities:
- 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.
Education:
- Required: MD, DO, or equivalent
- Preferred: Board Certification
Required Experience & Skills:
- 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
Required Skills:
Clinical Risk Management, Clinical Safety, Data Analysis, Detail-Oriented, Drug Safety Surveillance, FDA Submissions, Patient Safety, Pharmacovigilance, Safety Reporting
Preferred Skills:
- Oncology
Application:
- Apply via https://jobs.merck.com/us/en (application deadline listed on the posting).