Join to apply for the Director, Safety Physician role at Immunocore .
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The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry. This role involves contributing to medical oversight and safety evaluation within Pharmacovigilance and Risk Management. Responsibilities include proactive risk-benefit assessments, implementing safety strategies, guiding staff and vendors on adverse event processing, and collaborating with other functions such as Clinical Development, Regulatory Affairs, and Medical Affairs.
Key Responsibilities: Develop safety evaluation strategies for clinical studies, ensuring cross-functional agreement and updates based on safety data.
Lead safety reporting processes, ensuring consistency and data-driven decision-making.
Conduct medical reviews of individual case safety reports (ICSRs) with appropriate follow-up.
Ensure ICSRs are medically accurate, complete, and properly coded, with appropriate causality assessments.
Ensure timely and accurate safety reports from post-marketing surveillance and trials.
Identify safety signals through data analysis and literature review.
Manage safety data trending and signaling, contributing to safety governance.
Participate in safety management teams and safety-related regulatory responses.
Develop safety documentation such as RSI, labelling, and RMPs.
Collaborate with stakeholders on safety analyses and risk assessments.
Author safety sections of aggregate reports and safety responses to regulators.
Develop and maintain PV processes and SOPs.
Maintain knowledge of disease areas and ensure compliance with PV regulations.
Competencies: Strong clinical skills and collaboration abilities.
Experience with regulatory interactions and industry standards.
Influencing and ownership skills.
Analytical and problem-solving skills.
Ability to work remotely.
Experience & Knowledge: Pharmacovigilance experience, especially case review and safety data analysis.
Knowledge of clinical development and safety reporting.
Experience with safety databases and drug approval processes.
Education & Qualifications: M.D./D.O with ≥3 years pharmacovigilance and ≥2 years clinical experience.
About Immunocore: A biotech company developing T cell receptor therapies for oncology, infectious, and autoimmune diseases. Committed to innovation, diversity, and inclusion.
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