CSRM Physician - Senior Principal Scientist, Drug Safety
Merck
September 03, 2026
Remote friendly (Rahway, NJ)
United States
Medical Affairs
Primary Activities
- Chair and lead the Risk Management and Safety Team (RMST) and participate in product development activities for assigned products.
- Partner with clinical development and clinical research to ensure programs support robust safety assessment and benefit-risk evaluation in aggregate safety reports.
- Collaborate cross-functionally (clinical development, epidemiology, regulatory affairs, statistics, manufacturing) to manage safety topics aligned to global pharmacovigilance and risk management strategies.
- Evaluate safety data from multiple sources (clinical trials, literature, post-approval use) and ensure completeness of safety information in CCDS.
- Set scientific strategy for safety documents (CTD components, RMPs, PSURs) and ensure medical/scientific appropriateness of safety sections in product circulars.
- Oversee safety surveillance (aggregate trial data analysis, post-approval safety signaling reviews) using medical judgment; collaborate with CSRM Associate.
- Drive risk management activities (pharmacovigilance action recommendations, labeling recommendations, RMPs, risk minimization strategies) with CSRM Associate.
- Review/approve product labeling files in the safety database; demonstrate working knowledge of MedDRA.
- Prepare safety summaries/analyses for regulatory documents and may supervise medical associates’ safety data analysis and regulatory document authoring.
- Contribute to development and evaluation of department standards/processes/metrics.
Education
- Required: MD, DO, or equivalent
- Preferred: Board Certification
Required Experience and Skills
- 3+ years post-graduate clinical experience
- Prior drug development experience (clinical and/or regulatory)
- Experience in clinical safety, pharmacovigilance and/or risk management
- Organizational leadership
- Excellent communication, writing, analytic skills
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 instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Chair and lead the Risk Management and Safety Team (RMST) and participate in product development activities for assigned products.
- Partner with clinical development and clinical research to ensure programs support robust safety assessment and benefit-risk evaluation in aggregate safety reports.
- Collaborate cross-functionally (clinical development, epidemiology, regulatory affairs, statistics, manufacturing) to manage safety topics aligned to global pharmacovigilance and risk management strategies.
- Evaluate safety data from multiple sources (clinical trials, literature, post-approval use) and ensure completeness of safety information in CCDS.
- Set scientific strategy for safety documents (CTD components, RMPs, PSURs) and ensure medical/scientific appropriateness of safety sections in product circulars.
- Oversee safety surveillance (aggregate trial data analysis, post-approval safety signaling reviews) using medical judgment; collaborate with CSRM Associate.
- Drive risk management activities (pharmacovigilance action recommendations, labeling recommendations, RMPs, risk minimization strategies) with CSRM Associate.
- Review/approve product labeling files in the safety database; demonstrate working knowledge of MedDRA.
- Prepare safety summaries/analyses for regulatory documents and may supervise medical associates’ safety data analysis and regulatory document authoring.
- Contribute to development and evaluation of department standards/processes/metrics.
Education
- Required: MD, DO, or equivalent
- Preferred: Board Certification
Required Experience and Skills
- 3+ years post-graduate clinical experience
- Prior drug development experience (clinical and/or regulatory)
- Experience in clinical safety, pharmacovigilance and/or risk management
- Organizational leadership
- Excellent communication, writing, analytic skills
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 instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.