Clinical Safety and Risk Management Principal Scientist

About the role

The Clinical Safety and Risk Management Principal Scientist leads pharmacovigilance activities for assigned marketed products, chairing the Risk Management Safety Team (RMST) and ensuring safety surveillance aligns with global strategies.

Key responsibilities

• Chair the RMST and drive development and maintenance of risk management and pharmacovigilance plans.
• Collaborate with cross‑functional teams (clinical development, epidemiology, regulatory affairs, statistics, manufacturing) to evaluate safety data from trials, literature and post‑approval use.
• Lead scientific strategy for safety documents such as Risk Management Plans, Periodic Safety Update Reports and product labeling.
• Oversee safety surveillance activities, including aggregate data analysis, signal detection and case review, and supervise CSRM medical associates.
• Contribute to risk minimization actions, labeling recommendations and regulatory submissions.

Required profile

• Medical Doctor (MD) degree; medical specialty preferred.
• Minimum 2‑3 years clinical experience and at least 7 years total professional experience, with ≥4 years in safety/pharmacovigilance.
• Demonstrated leadership, strong communication in English and ability to manage programs and influence stakeholders.
• Proven problem‑solving, conflict‑resolution and critical‑thinking capabilities.

Required skills

• Adverse Drug Reaction (ADR) monitoring
• Pharmacovigilance and drug safety surveillance
• Risk management and risk minimization
• Periodic Safety Update Reports
• Safety databases and regulatory compliance
• Epidemiology and data analysis
• Clinical trial oversight and medical knowledge