Director, Safety Operations
Listed on 2026-01-25
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Healthcare
Healthcare Management
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
The Director, Safety Operations is a senior pharmacovigilance operations leader accountable for the end-to-end execution, quality, and continuous improvement of global safety operations for Immunocore's development and marketed products. The role holder is an experienced pharmacovigilance professional with deep expertise in case management, safety systems, PV compliance, and vendor oversight.
The role leads global case management, regulatory reporting, and safety operational processes across clinical and postmarketing settings, ensuring a robust, inspection ready PV system that meets GVP and other global regulatory requirements (e.g., MHRA, EMA, FDA, ICH, CIOMS). The Director oversees safety databases and related tools (including configuration, validation, and lifecycle management in partnership with IT and Safety Systems), manages external vendors/CROs, and builds a high performing Global Safety Operations team with direct line management responsibilities.
The role also partners closely with Safety Physicians and cross functional stakeholders to ensure high quality safety data supports signal detection, aggregate safety reporting, and benefit-risk assessment throughout the product lifecycle, providing both strategic direction and hands‑on operational leadership.
- Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies.
- Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources.
- Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics.
- Provide strategic leadership for the selection, configuration, validation, and life‑cycle management of safety systems and tools, in partnership with IT and Safety Systems teams.
- Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations.
- Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.
- Collabo…
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