Director, Safety Physician - #145088

Location of role US or UK

Department Regulatory Affairs

Key Responsibilities The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician 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 compliance with global regulations. This individual will provide 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. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

KEY RESPONSIBILITIES:

• Develop strategies for assigned projects for safety evaluation and reporting that provide a consistent approach to emerging safety findings from ongoing clinical studies. Gain cross-functional input and agreement with strategies and oversee implementation. Amend strategies based on increased understanding of the safety findings from regular individual cases and aggregate reports.
• Provide leadership across functions to consistently approach safety reporting for data collection to ensure consistency between PV and Clinical Operations and Clinical Development working as an integrated team based on data and pharmacovigilance perspective to support future labelling.
• Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
• Ensures ICSRs are medically accurate, complete, coded appropriately (MedDRA), with appropriate causality assessment, seriousness and expectedness.
• Ensures accuracy and timeliness of expedited reports and periodic reports from post-marketing surveillance and clinical trials.
• Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.
• Responsible for the review and communication of safety data trending, signaling and other safety-related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process.
• Participate in the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
• Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labelling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
• Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
• Author medical-safety sections of aggregate safety reports (DSUR, PBRER).
• Participate in development of safety-related responses to queries from Regulatory Authorities.
• Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.
• Maintain knowledge of Immunocore disease and therapeutic areas for marketed products and products in development.
• Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.).
  
  

COMPETENCIES:

• Communication Proficiency.
• Good clinical skills.
• Time Management.
• Collaboration Skills both internally and with outside parties.
• Personal Effectiveness/Credibility.
• Flexibility.
• Technical Capacity.
• Stress Management/Composure.
• Appropriate experience with Regulatory Agency and KOL interactions.
• Knowledge of pharmacovigilance relevant regulations, guidelines, and industry standards.
• Strong influencing skills with the ability to explain and defend a position in the face of opposition.
• Takes ownership of appropriate issues.
• Excellent analytical and problem-solving skills.
• Able to function in a remote office environment.
  
  

EXPERIENCE & KNOWLEDGE:

Essential

• Experience in Pharmacovigilance, particularly with individual case review and evaluation.
• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
• Knowledge of clinical development process.
• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
• Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
• Experience with different commercially available safety databases.
  
  

Desirable

• Knowledge of drug approval process in major countries.
  
  

EDUCATION & 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 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 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.

At Immunocore, we recognize 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.