Director, Safety Physician

Overview of Role: 

Reporting to the Vice President, Patient Safety & Pharmacovigilance (PSPV), the Director, Safety Physician is responsible for pharmacovigilance activities for investigational and marketed products. This role provides medical oversight of individual case safety reports (ICSRs), contributes strategically to adverse event monitoring and signal detection, supports compliance with global pharmacovigilance regulatory requirements, and helps protect patients participating in clinical trials or receiving company products. The role also provides safety-related medical input and guidance across the organization, as requested by the VP of PSPV. 

Role and Responsibilities: 

• Lead the medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments, to ensure high-quality and medically accurate reports. 

• Prepare Analyses of Similar Events (AOSEs) to support IND safety reports. 

• Confirm criteria and content for expedited safety reporting and unblinding decisions, including SUSARs and urgent safety issues. 

• Lead or actively contribute to the preparation and presentation of safety information for the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal or external stakeholders, as needed. 

• Review study protocols, including Sponsored Study, Investigator-Sponsored Trial, and Collaborative Study protocols for accuracy of safety-related content, and for assessment of overlapping toxicities with approved or investigational agents used in combination with Summit compounds. 

• Interact and liaise with pharmacovigilance vendor medical reviewers and company Medical Monitors. 

• Review individual and aggregate safety data from the safety database on a scheduled basis to support signal detection. 

• Serve as product lead and/or therapeutic area lead, as assigned. 

• Identify and communicate ICSR case quality issues to PV Operations, as appropriate, and support quality assurance activities related to ICSR medical review. 

• Implement appropriate case follow-up and query activities in accordance with applicable SOPs. 

• Develop and support medical coding conventions and systematic process improvements for ICSR medical review. 

• Support reconciliation activities between Safety and Clinical databases. 

• Develop, maintain, update, review, and approve the list of expected terms in the Reference Safety Information (RSI) within the Investigator’s Brochure, in collaboration with development partners and cross-functional teams. 

• Serve as a Medical Safety Review process lead, and support the development, training, and implementation of new Medical Safety Review processes. 

• Mentor Safety Physicians / Medical Safety Reviewers, as needed, and provide direct management of Safety Physicians / Medical Safety Reviewers when assigned. 

• Maintain inspection readiness and serve as the functional representative and point of contact for health authority inspections and internal process audits within the scope of the role. 

• Provide expertise and guidance for interdepartmental and cross-functional initiatives, including process improvement, standards development, SOP creation, and metrics related to medical safety review. 

• Author, review, and/or approve safety content for aggregate safety documents, including DSURs, PBRERs, regulatory responses, safety signal evaluations, and related documents, as requested. 

• Perform other position-related duties as defined in SOPs or as requested by the supervisor. 

• Perform all other duties as assigned. 

Experience, Education and Specialized Knowledge and Skills: 

• MD, DO, or international equivalent with a minimum of 10 years of relevant experience as a safety physician. 

• Working knowledge of case management and medical review processes and procedures. 

• Clinical knowledge of oncology patient populations and relevant drug classes, including immunotherapy and chemotherapy; oncology experience is preferred. 

• Proficiency with safety database systems, strong computer skills including spreadsheet and signal detection programs. 

• Strong understanding of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection for clinical trial and post-marketing safety. 

• Experience analyzing safety data and writing study-related narratives, aggregate reports, and safety assessments. 

• Demonstrated ability to work effectively both independently and in cross-functional team environments, including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory. 

• Experience with MedDRA coding and search strategies. 

• High level of attention to detail, accuracy, and confidentiality. 

• Clear, concise oral and written communication skills. 

• Excellent organizational, critical thinking, and problem-solving skills. 

• Ability to manage multiple priorities, including time-sensitive and highly confidential documents. 

• Ability to communicate complex ideas clearly and effectively to varied audiences. 

• Ability to prioritize competing demands. 

• Ability to work successfully in a fast-paced, demanding, and collaborative environment.