Clinical Safety & Risk Management Associate Principal Scientist

About the role

The Clinical Safety and Risk Management Associate Principal Scientist conducts primary medical review of serious adverse event reports and other safety data to monitor and describe the safety profile of assigned pharmaceutical products. The role works closely with the CSRM physician and the Risk Management Safety Team to develop and maintain pharmacovigilance and risk management plans.

Key responsibilities

• Perform primary medical review of serious adverse experience (AE) reports and other safety reports, including individual case assessments and aggregate data analysis.
• Collaborate with the CSRM physician to develop, maintain, and monitor pharmacovigilance and risk management plans (RMPs) and REMS for assigned products.
• Prepare accurate safety responses to inquiries from health professionals, regulatory agencies, and internal stakeholders.
• Analyze safety data from internal databases, literature, and external sources to identify safety signals and support regulatory submissions such as PSURs and DSURs.
• Represent CSRM on cross‑functional teams, contributing to risk assessment, mitigation strategies, and regulatory communications.

Required profile

• Minimum 5 years of professional experience in clinical and pharmaceutical settings, including at least 2 years in drug safety or pharmacovigilance with causality assessment and safety document authoring.
• Medical Doctor (MD) degree or equivalent clinical qualification.
• Proven ability to write scientific safety narratives and regulatory documents in English.
• Experience presenting safety data and influencing cross‑functional teams.

Required skills

• Pharmacovigilance and risk management expertise
• Medical writing and safety reporting (PSUR, DSUR)
• Data analysis and epidemiology
• Use of safety databases and MS Office applications
• Clinical judgment and critical thinking