Senior Director, Global Pharmacovigilance (Safety Physician)

BioSpace; Radnor (Delaware County); A distancia; USD 188.000 - 312.000; Jornada completa

Descripción de la vacante

Immunocore is seeking a Senior Director, Global Pharmacovigilance (Safety Physician) to lead medical safety strategy for development and marketed products. The role oversees signal detection, regulatory submissions, and risk management, guiding a team of PV physicians and safety professionals across the product lifecycle.

This senior medical leader will interact with global Health Authorities, shape PV plans, and ensure high-quality safety reporting and lifecycle safety management for complex

Formación

• MD/DO 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.
• Board certification in a relevant specialty.

Responsabilidades

• 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.

Conocimientos

Pharmacovigilance leadership

Signal detection

Regulatory submissions

Team leadership

Educación

MD/DO degree

Herramientas

MedDRA

PV databases

Descripción del empleo

Vacancy Name Senior Director, Global Pharmacovigilance (Safety Physician) Vacancy No VN756 Employment Type Full Time Location of role Gaithersburg, MD, Radnor, PA, Remote, US 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 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.

• 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 IC…
• 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 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
• US Salary Range $187,500-$312,000
• 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 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.
• 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.