Vacancy Name: Senior Director Global Pharmacovigilance Safety Physician
Vacancy No.: VN756
Employment Type: Full Time
Location of role: Gaithersburg, MD Radnor, PA
Department: Regulatory Affairs
Key Responsibilities:
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 Immunocores 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.
Key aspects of the role include:
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, Investigators 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 Immunocores 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 process. • Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality. • Demonstrated track record in Authoring or overseeing aggregate safety reports, DSURs, PSURs, PBRERs, PADERs, and contributing to major regulatory submissions (e.g., BLA, MAA, and subsequent labelling updates).
Desirable:
• Advanced degree in epidemiology, pharmacology, or biomedical sciences (PhD, MPH). • Knowledge of drug approval process in major countries. • Experience with different commercially available safety databases. • Board certification in a relevant specialty. • Experience with global product launches and implementation assessment of complex risk minimisation measures. • Evidence of scientific contributions to the field (e.g., peer-reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).
EDUCATION & QUALIFICATIONS
• M.D., D.O. degree with at least five years of pharmacovigilance experience and at least two years of clinical experience or relevant experience to understand clinical drug development. • At least five years of practical clinical experience post licensure.
About the Company
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 addressing unmet patient needs in oncology, infectious diseases, and autoimmune diseases. Our leaders in R&D are internationally recognised as some of the biotech industrys 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 recognise 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.