Immunocore
Director Safety Physician, Global Pharmacovigilance
Immunocore, Conshohocken, Pennsylvania, United States
Overview
Director Safety Physician, Global Pharmacovigilance at Immunocore. The Director Safety Physician is a physician with robust medical and scientific expertise in clinical medicine, clinical safety evaluation, and pharmacovigilance. The role leads proactive and timely benefit–risk assessments, drives advanced signal detection and analyses from diverse data sources (clinical trials, post-market surveillance, real-world data), and shapes the evolving safety profiles of Immunocore’s development and marketed products. The role is responsible for the successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company’s business strategy, industry standards and global regulations. This position provides guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post-marketing surveillance, and collaborates closely with cross-functional teams such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Key Responsibilities
Drive the strategic vision and execution of safety surveillance and benefit–risk assessment across the product life cycle, including development and refinement of project-level safety evaluation and reporting strategy.
Ensure alignment with clinical and regulatory objectives, gain cross-functional agreement, and adapt strategies based on evolving insights from single cases and aggregate data.
A n t i c i p a t e and shape emerging safety issues by creating strategic benefit–risk frameworks that inform labeling, clinical trial design, and post-marketing commitments.
Ensure consistency in approaches to emerging safety findings from clinical studies, gain cross-functional alignment, oversee implementation, and adapt strategies based on evolving insights from individual cases and aggregate data.
Provide medical and scientific leadership in signal detection, analysis, and input into governance forums, setting cross-functional safety strategy and providing recommendations that impact corporate decision‑making.
Provide cross-functional leadership to ensure consistency in safety data collection and reporting for the assigned products.
Provide medical review of case safety reports (ICSRs), including causality, seriousness, expectedness, and clinical relevance, ensuring medical accuracy and regulatory compliance.
Ensure accuracy and timeliness of expedited reports and periodic reports from clinical trials and post-marketing surveillance.
Participate in identification, analysis and reporting of trends and concerns with company products, including safety signals through assessment of single case safety reports, aggregate trend analyses, and literature reviews.
Responsible for signal detection and evaluation, conducting scientific analyses of clinical trial, post‑marketing, literature, and epidemiological data to support timely risk identification and mitigation.
Lead the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and recommendations related to safety issues.
Accountable for the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Company Core Safety Information, Investigator Brochure, national labels), Risk Management Plans.
Provide medical and scientific input into responses to regulatory authority queries regarding product safety and risk management.
Guide internal collaborators and external vendors in best practices for safety data collection, coding, analyses and evaluation, ensuring high-quality standards.
Oversee the preparation and review of safety sections of regulatory submissions, including DSURs, PBRERs, RMPs, Investigator Brochures, and labeling updates.
Ensure medical and scientific accuracy and quality of aggregate safety reports (DSUR, PBRER), risk management plans, and safety sections of health authority queries, protocols, and investigator brochures.
Author medical-safety sections of submission documents (Summary of Clinical Safety, Clinical Overview).
Maintain up-to-date knowledge of Immunocore therapeutic areas and global regulatory requirements for pharmacovigilance.
Participate in development of internal PV infrastructure including standard operating procedures and work practices to ensure seamless PV processes.
SUPERVISORY RESPONSIBILITIES: This position will not have line manager responsibilities, but provides safety leadership to cross-functional teams.
Core Competencies
Strong medical and clinical judgment in evaluating adverse event data and benefit–risk profiles.
Strong scientific and analytical skills with the ability to translate data into actionable insights.
Collaborative leadership in cross-functional activities with effective communication of complex concepts to medical and non-medical audiences.
Knowledge of global PV regulations and risk management requirements (FDA, EMA, ICH, CIOMS).
Knowledge & Experience
Experience with signal detection and review of aggregate data to identify potential emerging safety issues, benefit‑risk assessment, and risk management strategies.
Experience in authoring aggregate safety reports for regulator submission.
Knowledge of clinical development process and ability to prioritise multiple tasks and meet deadlines.
Desirable Qualifications
Advanced degree (PhD/MPH) in epidemiology, pharmacology, or biomedical sciences.
Knowledge of drug approval processes in major markets; experience with different commercially available safety databases.
Board certification in a relevant specialty; experience in regulatory submissions and interactions.
Essential Qualifications
M.D./D.O. degree with at least three years of pharmacovigilance experience and at least two years of clinical experience or relevant experience to understand clinical drug development.
At least three years of practical clinical experience.
About Immunocore Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company focused on developing transformative medicines for oncology, infectious diseases and autoimmune diseases. We are committed to STRIDE values: Science, Trust, Respect, Integrity, Diversity and Entrepreneurship.
Location Location: US or UK (role based in the United States or United Kingdom)
Additional Details
Employment type: Full-time
Job function: Science
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr
Director Safety Physician, Global Pharmacovigilance at Immunocore. The Director Safety Physician is a physician with robust medical and scientific expertise in clinical medicine, clinical safety evaluation, and pharmacovigilance. The role leads proactive and timely benefit–risk assessments, drives advanced signal detection and analyses from diverse data sources (clinical trials, post-market surveillance, real-world data), and shapes the evolving safety profiles of Immunocore’s development and marketed products. The role is responsible for the successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company’s business strategy, industry standards and global regulations. This position provides guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post-marketing surveillance, and collaborates closely with cross-functional teams such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Key Responsibilities
Drive the strategic vision and execution of safety surveillance and benefit–risk assessment across the product life cycle, including development and refinement of project-level safety evaluation and reporting strategy.
Ensure alignment with clinical and regulatory objectives, gain cross-functional agreement, and adapt strategies based on evolving insights from single cases and aggregate data.
A n t i c i p a t e and shape emerging safety issues by creating strategic benefit–risk frameworks that inform labeling, clinical trial design, and post-marketing commitments.
Ensure consistency in approaches to emerging safety findings from clinical studies, gain cross-functional alignment, oversee implementation, and adapt strategies based on evolving insights from individual cases and aggregate data.
Provide medical and scientific leadership in signal detection, analysis, and input into governance forums, setting cross-functional safety strategy and providing recommendations that impact corporate decision‑making.
Provide cross-functional leadership to ensure consistency in safety data collection and reporting for the assigned products.
Provide medical review of case safety reports (ICSRs), including causality, seriousness, expectedness, and clinical relevance, ensuring medical accuracy and regulatory compliance.
Ensure accuracy and timeliness of expedited reports and periodic reports from clinical trials and post-marketing surveillance.
Participate in identification, analysis and reporting of trends and concerns with company products, including safety signals through assessment of single case safety reports, aggregate trend analyses, and literature reviews.
Responsible for signal detection and evaluation, conducting scientific analyses of clinical trial, post‑marketing, literature, and epidemiological data to support timely risk identification and mitigation.
Lead the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and recommendations related to safety issues.
Accountable for the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Company Core Safety Information, Investigator Brochure, national labels), Risk Management Plans.
Provide medical and scientific input into responses to regulatory authority queries regarding product safety and risk management.
Guide internal collaborators and external vendors in best practices for safety data collection, coding, analyses and evaluation, ensuring high-quality standards.
Oversee the preparation and review of safety sections of regulatory submissions, including DSURs, PBRERs, RMPs, Investigator Brochures, and labeling updates.
Ensure medical and scientific accuracy and quality of aggregate safety reports (DSUR, PBRER), risk management plans, and safety sections of health authority queries, protocols, and investigator brochures.
Author medical-safety sections of submission documents (Summary of Clinical Safety, Clinical Overview).
Maintain up-to-date knowledge of Immunocore therapeutic areas and global regulatory requirements for pharmacovigilance.
Participate in development of internal PV infrastructure including standard operating procedures and work practices to ensure seamless PV processes.
SUPERVISORY RESPONSIBILITIES: This position will not have line manager responsibilities, but provides safety leadership to cross-functional teams.
Core Competencies
Strong medical and clinical judgment in evaluating adverse event data and benefit–risk profiles.
Strong scientific and analytical skills with the ability to translate data into actionable insights.
Collaborative leadership in cross-functional activities with effective communication of complex concepts to medical and non-medical audiences.
Knowledge of global PV regulations and risk management requirements (FDA, EMA, ICH, CIOMS).
Knowledge & Experience
Experience with signal detection and review of aggregate data to identify potential emerging safety issues, benefit‑risk assessment, and risk management strategies.
Experience in authoring aggregate safety reports for regulator submission.
Knowledge of clinical development process and ability to prioritise multiple tasks and meet deadlines.
Desirable Qualifications
Advanced degree (PhD/MPH) in epidemiology, pharmacology, or biomedical sciences.
Knowledge of drug approval processes in major markets; experience with different commercially available safety databases.
Board certification in a relevant specialty; experience in regulatory submissions and interactions.
Essential Qualifications
M.D./D.O. degree with at least three years of pharmacovigilance experience and at least two years of clinical experience or relevant experience to understand clinical drug development.
At least three years of practical clinical experience.
About Immunocore Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company focused on developing transformative medicines for oncology, infectious diseases and autoimmune diseases. We are committed to STRIDE values: Science, Trust, Respect, Integrity, Diversity and Entrepreneurship.
Location Location: US or UK (role based in the United States or United Kingdom)
Additional Details
Employment type: Full-time
Job function: Science
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr