Senior Director, Global Pharmacovigilance (Safety Physician)
Immunocore
August 24, 2026
Remote friendly (Radnor, PA)
United States
Medical Affairs
Key Responsibilities:
- Develop and implement global pharmacovigilance strategies for assigned products.
- Lead ongoing benefit–risk assessments using clinical trials, post-marketing surveillance, real-world data, and active safety studies.
- Oversee systematic signal detection/evaluation from ICSRs, aggregate/periodic reports, literature, and other sources.
- Direct design, conduct, and interpretation of active safety surveillance and pharmacoepidemiology studies to characterize and quantify risks.
- Lead multidisciplinary Safety Management/Safety Review Teams for signal evaluation, surveillance strategies, and risk mitigation.
- Ensure medical/scientific quality of aggregate safety reports, PV plans/RMPs, Investigator’s Brochures, and safety sections of regulatory submissions.
- Provide senior medical safety leadership for global regulatory submissions, labeling negotiations, and responses to Health Authority queries.
- Oversee medical review of ICSRs (causality, seriousness, expectedness, clinical relevance).
- Guide internal teams and external vendors/CROs on safety data collection, coding (e.g., MedDRA), evaluation, and database/analytics tool use.
- Serve as senior safety representative on cross-functional teams to integrate safety into study design and decisions.
- Lead continuous improvement of PV processes, SOPs, and tools.
Supervisory Responsibility: No line manager responsibilities; provides safety leadership to cross-functional teams.
Essential Experience & Knowledge:
- Signal detection and aggregate data review for emerging safety issues, benefit–risk, and risk management.
- Preparation/contribution to aggregate safety reports for regulators.
- Knowledge of clinical development process.
- Ability to prioritize and meet deadlines with high quality.
- Track record authoring/overseeing DSURs, PSURs/PBRERs, PADERs and contributing to BLA/MAA submissions and labeling updates.
Desirable:
- Advanced degree (PhD/MPH) in epidemiology/pharmacology/biomedical sciences.
- Knowledge of major-country drug approval processes; experience with safety databases; board certification.
- Experience with global launches and risk minimization.
- Scientific contributions (publications, presentations, guideline development).
Education & Qualifications:
- M.D./D.O. with 5+ years pharmacovigilance experience and 2+ years clinical (or relevant) experience.
- 5+ years practical clinical experience post-licensure.
US Salary Range: $187,500–$312,000
- Develop and implement global pharmacovigilance strategies for assigned products.
- Lead ongoing benefit–risk assessments using clinical trials, post-marketing surveillance, real-world data, and active safety studies.
- Oversee systematic signal detection/evaluation from ICSRs, aggregate/periodic reports, literature, and other sources.
- Direct design, conduct, and interpretation of active safety surveillance and pharmacoepidemiology studies to characterize and quantify risks.
- Lead multidisciplinary Safety Management/Safety Review Teams for signal evaluation, surveillance strategies, and risk mitigation.
- Ensure medical/scientific quality of aggregate safety reports, PV plans/RMPs, Investigator’s Brochures, and safety sections of regulatory submissions.
- Provide senior medical safety leadership for global regulatory submissions, labeling negotiations, and responses to Health Authority queries.
- Oversee medical review of ICSRs (causality, seriousness, expectedness, clinical relevance).
- Guide internal teams and external vendors/CROs on safety data collection, coding (e.g., MedDRA), evaluation, and database/analytics tool use.
- Serve as senior safety representative on cross-functional teams to integrate safety into study design and decisions.
- Lead continuous improvement of PV processes, SOPs, and tools.
Supervisory Responsibility: No line manager responsibilities; provides safety leadership to cross-functional teams.
Essential Experience & Knowledge:
- Signal detection and aggregate data review for emerging safety issues, benefit–risk, and risk management.
- Preparation/contribution to aggregate safety reports for regulators.
- Knowledge of clinical development process.
- Ability to prioritize and meet deadlines with high quality.
- Track record authoring/overseeing DSURs, PSURs/PBRERs, PADERs and contributing to BLA/MAA submissions and labeling updates.
Desirable:
- Advanced degree (PhD/MPH) in epidemiology/pharmacology/biomedical sciences.
- Knowledge of major-country drug approval processes; experience with safety databases; board certification.
- Experience with global launches and risk minimization.
- Scientific contributions (publications, presentations, guideline development).
Education & Qualifications:
- M.D./D.O. with 5+ years pharmacovigilance experience and 2+ years clinical (or relevant) experience.
- 5+ years practical clinical experience post-licensure.
US Salary Range: $187,500–$312,000