Senior Director, Global Pharmacovigilance; Safety Physician

Position: Senior Director, Global Pharmacovigilance (Safety Physician)
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Senior Director, Global Pharmacovigilance (Safety Physician)|  | Senior Director, Global Pharmacovigilance (Safety Physician) ||  | Gaithersburg, MD, Radnor, PA ||  | The Senior Director, Global Pharmacovigilance (Safety Physician) is a senior medical leader accountable for the global medical safety strategy, benefit–risk assessment, and risk management of Immunocore’s development and marketed products. The role holder is a board-certified physician and recognized subject matter expert in pharmacovigilance, with deep experience in biologic product safety, signal detection, epidemiology, and regulatory benefit–risk decision making (e.g., FDA, EMA and other Health Authorities), providing strategic and operational leadership across all phases of the product lifecycle from early development through post marketing.
Key aspects of the role include leading proactive, data driven benefit–risk assessment and advanced signal detection using clinical trial, post marketing, and real world data; shaping and executing global Pharmacovigilance Plans and Risk Management Plans, including the design and interpretation of post authorization safety and active surveillance studies; directing and developing a team of pharmacovigilance physicians and safety professionals by setting strategy, building capabilities, and embedding best practices aligned with Immunocore’s Senior Director career framework;

and serving as the senior medical safety authority for assigned products, representing Immunocore in high level interactions with global Health Authorities and external partners.

KEY RESPONSIBILITIES    
• Develop and implement global pharmacovigilance strategies for assigned products, aligned with clinical, regulatory, and commercial objectives.  
• Lead ongoing benefit–risk assessments using data from clinical trials, post marketing surveillance, real world data sources, and epidemiologic/active safety studies.  
• Oversee systematic signal detection and evaluation from Individual Case Safety Reports, aggregate/periodic reports, literature, and other data sources.  
• Direct the design, conduct, and interpretation of active safety surveillance and pharmacoepidemiology studies to characterise and quantify product risks.  
• Lead multidisciplinary Safety Management/Safety Review Teams to drive signal evaluation, surveillance strategies, and risk mitigation recommendations.  
• Be accountable for the medical and scientific quality of aggregate safety reports, Pharmacovigilance Plans/RMPs, Investigator’s Brochures, and safety sections of regulatory submissions.  
• Provide senior medical safety leadership for global regulatory submissions and labelling negotiations, and respond to Health Authority queries on product safety, benefit–risk, and risk management.  
• Provide senior level oversight of medical review of ICSRs, ensuring accurate assessment of causality, seriousness, expectedness, and clinical relevance.  
• Guide internal teams and external vendors/CROs on best practices for safety data collection, coding (e.g., MedDRA), evaluation, and use of safety databases and analytics tools.  
• Serve as the senior safety representative on cross functional clinical and project teams, ensuring integrated safety input into study design, protocols, analyses, and portfolio decisions.  
• Champion cross functional collaboration and engagement with external stakeholders to shape Immunocore’s safety strategy and external scientific profile.  
• Lead continuous improvement of PV processes, SOPs, and tools, and maintain current knowledge of evolving pharmacovigilance and biologic safety guidance.
SUPERVISORY RESPONSIBILITY  This position will not have line manager responsibilities, but provides safety leadership to cross functional teams    EXPERIENCE & KNOWLEDGE    Essential  
• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.  
• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.  
• Knowledge of clinical development…