Director Safety Physician, Global Pharmacovigilance

Overview of the Director Safety Physician, Global Pharmacovigilance role at Immunocore. Location: US or UK. Department: Regulatory Affairs.

Key Responsibilities:

• Drive the strategic vision and execution of safety surveillance and benefit–risk assessment across the life cycle of assigned products, including the development and refinement of project-level safety evaluation and reporting strategies.
• Ensure alignment with clinical and regulatory objectives, gain cross-functional agreement, and adapt strategies based on evolving insights from single cases and aggregate data.
• Anticipate and shape emerging safety issues by creating strategic benefit–risk frameworks that inform labeling, clinical trial design, and post-marketing commitments.
• Provide medical and scientific leadership in signal detection, analysis, and input into governance forums, setting cross-functional safety strategy and providing recommendations that impact corporate decision-making.
• Provide cross-functional leadership to ensure consistency in safety data collection and reporting for the assigned products.
• Provide medical review of case safety reports (ICSRs), ensuring medical accuracy and regulatory compliance.
• Ensure accuracy and timeliness of expedited reports and periodic reports from clinical trials and post-marketing surveillance.
• Participate in the identification, analysis and reporting of possible trends and concerns with company products.
• Responsible for signal detection and evaluation, conducting scientific analyses of clinical trial, post-marketing, literature, and epidemiological data to support timely risk identification and mitigation.
• Lead the multidisciplinary Safety Management Team whose responsibilities include safety surveillance, risk management planning, and making recommendations related to safety issues.
• Accountable for the preparation and maintenance of Reference Safety Information (RSI) and product labelling.
• Guide internal collaborators and external vendors in best practices for safety data collection, coding, analyses and evaluation, ensuring high-quality standards.
• Oversee the preparation and review of safety sections of regulatory submissions.
• Accountable for the medical and scientific accuracy and quality of aggregate safety reports and safety sections of health authority queries.
• Maintain up-to-date knowledge of Immunocore therapeutic areas and global regulatory requirements for PV.
• Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions.

Supervisory Responsibility: This position will not have line manager responsibilities, but provides safety leadership to cross functional teams.

Competencies:

• Strong medical and clinical judgment in evaluating adverse event data and benefit–risk profiles.
• Strong scientific and analytical skills, with the ability to translate data into meaningful insights.
• Collaborative leadership in cross-functional activities.
• Effectively communicate/present complex scientific and medical concepts to both medical and non-medical audiences.
• Knowledge of global PV regulations and risk management requirements (FDA, EMA, ICH, CIOMS).