Clinical Safety and Risk Management Associate Principal Scientist

MSD

. Perform medical review of serious adverse event (SAE) reports and selected non-serious adverse events to support ongoing safety surveillance .

Posted 4/21/2026full-timePrague • CzechiaJuniorMid-LevelWebsite

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

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Applicant Tracking System Keywords

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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)