Clinical Safety and Risk Management Associate Principal Scientist

About the role

The Clinical Safety and Risk Management Associate Principal Scientist conducts primary medical review of serious adverse experience reports and other safety data to monitor and describe the safety profile of assigned pharmaceutical products. Working closely with the CSRM physician, the role supports the development and oversight of pharmacovigilance and risk management plans.

Key responsibilities

• Perform safety surveillance reviews of individual adverse event reports, aggregate data, published literature and external databases.
• Collaborate with the CSRM physician to select, extract and analyse data from IT systems for safety investigations.
• Prepare accurate responses to safety inquiries from healthcare professionals, regulatory agencies and internal stakeholders.
• Contribute to regulatory documents such as PSURs, DSURs and other safety summaries.
• Represent CSRM on cross‑functional teams, assisting the Risk Management Safety Team in developing and maintaining RMPs and REMS.
• Participate in the creation, implementation and evaluation of departmental standards, processes and metrics.

Required profile

• Minimum two years of clinical experience in a patient‑care setting.
• At least five years of professional experience in the pharmaceutical industry, including a minimum of two years in safety (pharmacovigilance or clinical) with causality assessment and safety document authoring.
• Demonstrated knowledge of pharmacovigilance, risk management and regulatory safety reporting.

Required skills

• Clinical, pharmacological and epidemiologic knowledge applied to safety surveillance.
• Proficiency with information‑technology tools used for safety data management.
• Ability to analyse aggregate safety data and prepare regulatory safety summaries.