Senior Director, Global Pharmacovigilance (Safety Physician)
Scorpion Therapeutics, Gaithersburg
Role Summary
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. Location: Gaithersburg, MD; Radnor, PA.
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.
Qualifications
- Required: Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
- Required: Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
- Required: Knowledge of clinical development process
- Required: Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
- Required: 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.
- Preferred: Advanced degree in epidemiology, pharmacology, or biomedical sciences (PhD/MPH).
- Preferred: Knowledge of drug approval process in major countries.
- Preferred: Experience with different commercially available safety databases.
- Preferred: Board certification in a relevant specialty.
- Preferred: Experience with global product launches and implementation/assessment of complex risk minimisation measures.
- Preferred: 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
- 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