Director, Drug Safety Physician

Role Summary:

The Director, Drug Safety Physician will lead the Drug Safety & Pharmacovigilance (DSPV) team, overseeing critical deliverables such as Individual Case Safety Report (ICSR) review, aggregate safety monitoring (DSUR), expedited safety reporting for Analysis of Similar Events (AOSEs), and safety assessments. Responsibilities include contributing to safety surveillance, signal detection, risk management planning, and ensuring compliance with global regulatory requirements. This role reports to the Sr VP, Drug Safety and Pharmacovigilance with a dotted line to the Medical Review Lead.

Key Responsibilities:

• Perform triage and medical review of ICSRs (in and/or outside the global safety database) and oversee expedited safety reporting for cases/AOSEs
• Lead cross-functional medical review discussions on ICSR reviews
• Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of clinical trial documents and regulatory filings
• Review scientific literature and prepare written summaries for aggregate safety analyses
• Participate in safety data review, including surveillance activities and evaluation/management of emerging safety signals
• Present cases at Safety Management Team (SMT) and Safety Review Team (SRT) meetings and co-lead safety surveillance and signal management meetings
• Engage in process improvement projects related to medical review, safety surveillance, and pharmacovigilance compliance
• Assist in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes, including SOPs, work instructions (WI), safety management plans, and surveillance plans
• Participate in safety presentations for Independent Data Monitoring Committee (iDMC) meetings
• Collaborate with the Medical Review Lead and team on ongoing case reviews, unified medical review approaches for ICSRs, safety presentations, and input into study protocols, DSURs, safety management plans, and epidemiology projects (natural history of disease, comorbidities, class effects, population health data, real-world drug safety monitoring, literature searches, signal detection, comparative effectiveness, and safety research)
• Ensure all activities are executed efficiently with quality, accuracy, and timeliness while adhering to global regulatory requirements
• Provide medical safety strategy and execute benefit-risk management strategies for assigned products
• Offer safety input to clinical development plans and responses to health authority or institutional review board/ethics committee queries
• Develop safety risk language, risk management strategies, and pre-filing safety activities, including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development
• Perform other duties as assigned

Ideal Candidate:

• MD with 6+ years of related experience in Clinical Development Drug Safety/Medical Review within the biotech/pharmaceutical industry, specializing in medical review of ICSRs and periodic reports
• A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health) or extensive working knowledge in Epidemiology/Pharmacoepidemiology is highly preferred
• Proficiency in Argus global safety database and experience in medical review activities
• Experience in safety surveillance and signal detection
• 2-3 years of Medical Device safety experience is a strong preference
• Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the role
• Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
• Strong communication and interpersonal skills, with the ability to motivate teams and collaborate across functions