Principal Scientist, Clinical Safety and Risk Management

MSD

CSRM Physician leading clinical risk management and safety surveillance for marketed products. Collaborating with various teams and overseeing safety data evaluations and reports.

Posted 7/3/2026full-timePrague • CzechiaLeadWebsite

About the role

Key responsibilities & impact

Lead the overall clinical risk management and safety surveillance of assigned marketed products
Chair the Risk Management and Safety Team (RMST) for assigned products
Participate in internal and joint internal/external research project teams
Collaborate with cross-functional team members including clinical development, epidemiology, regulatory affairs, statistics, and manufacturing
Conduct safety data evaluation, assessing safety from multiple sources (clinical trials, literature, post-approval use)
Accountable for scientific strategy for safety related documents (e.g. Risk Management Plans (RMP) and Periodic Safety Update Reports)
Responsible for safety surveillance activities such as aggregate data analysis and post approval safety signalling reviews
Collaborate with CSRM Associate to oversee all safety surveillance activities
Contribute to recommendations for pharmacovigilance actions and developing risk minimization activities
Prepare safety summaries and analyses of safety related data for regulatory documents

Requirements

What you’ll need

Medical Doctor (MD)
Minimum of 2-3 years clinical experience (in a patient care setting) following post-graduate medical training or other relevant clinical experience
Minimum 7 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 4 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents
Demonstrated organizational leadership skills
Excellent communication, and writing skills in English
Demonstrated skills in managing programs, processes, and facilitating meetings
Effective presentation skills and experience influencing and negotiating
Problem solving, conflict resolution and critical thinking skills

Benefits

Comp & perks

Flexible Work Arrangements: Hybrid
Professional development opportunities
Health insurance
Relocation assistance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Safety Data EvaluationRisk Management Plans (RMP)Periodic Safety Update ReportsCausality AssessmentSafety Document Authoring

Soft Skills

Organizational LeadershipExcellent CommunicationEffective PresentationProblem SolvingConflict Resolution