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Clinical Safety and Risk Management Associate Principal Scientist
MSDClinical Safety and Risk Management Associate Principal Scientist responsible for monitoring and assessing medicine safety. Collaborating with teams to manage safety risks and develop regulatory deliverables.
About the role
Key responsibilities & impact- Perform medical review of serious adverse event (SAE) reports and selected non-serious adverse events to support ongoing safety surveillance
- Monitor and evaluate the overall safety profile of assigned products using individual case reports, aggregate safety data, scientific literature, and external databases
- Identify, investigate, and support assessment of safety signals in collaboration with CSRM physicians
- Select, analyze, and interpret safety data from validated safety and IT systems to support issue management and decision-making
- Contribute to the development, maintenance, and monitoring of Risk Management Plans (RMPs) and, where applicable, Risk Evaluation and Mitigation Strategies (REMS)
- Prepare and support high-quality responses to safety inquiries from health care professionals, regulatory authorities, affiliates, and internal stakeholders
- Author and contribute to safety sections of regulatory documents, including PSURs, DSURs, and summaries supporting regulatory submissions
- Act as a core member of the Risk Management Safety Team (RMST) and represent CSRM on cross-functional teams and governance forums as appropriate
Requirements
What you’ll need- Medical Doctor (MD)
- Minimum 5 years of relevant professional experience combining clinical practice and pharmaceutical or biopharmaceutical industry experience
- At least 2 years must include drug safety, pharmacovigilance, or clinical safety experience (e.g., medical review, causality assessment, aggregate data analysis, safety document authoring)
- At least 2 years of post-qualification clinical experience as a fully licensed physician, independently diagnosing and treating patients in a clinical care setting
- Solid working knowledge of pharmacovigilance and risk management principles
- Strong written and verbal communication skills in English
- Experience working with safety databases and standard IT tools (e.g., MS Office)
- Proven experience authoring or contributing to regulatory safety documents (e.g., PSURs, DSURs, safety summaries)
Benefits
Comp & perks- Health insurance
- Flexible Work Arrangements
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug safetypharmacovigilanceclinical safetymedical reviewcausality assessmentaggregate data analysissafety document authoringrisk management principlessafety data analysissafety signal assessment
Soft Skills
strong written communicationstrong verbal communicationcollaborationdecision-makingissue management
Certifications
Medical Doctor (MD)