Director, Drug Safety Physician

Accountabilities:

As Director, Drug Safety Physician, you will provide medical expertise across drug safety and pharmacovigilance activities, supporting assigned development programs from ongoing safety review through regulatory interactions and benefit-risk management. You will work closely with medical, clinical, and cross-functional colleagues to ensure safety activities are timely, accurate, scientifically rigorous, and aligned with global requirements.

• Perform triage and medical review of Individual Case Safety Reports (ICSRs), both within and outside the global safety database.
• Oversee cases and Analysis of Similar Events (AOSEs) supporting expedited safety reporting.
• Lead cross-functional medical review discussions related to ICSR assessment.
• Participate in preparing, writing, and reviewing aggregate safety reports, including DSURs.
• Review safety sections of clinical trial documents and regulatory submissions.
• Lead or contribute to scientific literature reviews and prepare written summaries supporting aggregate safety analyses.
• Participate in safety surveillance activities and evaluate emerging safety signals from multiple data sources.
• Support the assessment, management, and monitoring of identified safety signals.
• Participate in and co-present cases at Safety Management Team and Safety Review Team meetings.
• Co-lead safety surveillance and signal management meetings.
• Develop safety presentations for independent Data Monitoring Committee meetings.
• Provide medical safety input into clinical development plans, study protocols, periodic safety reports, and safety management plans.
• Provide safety strategy and execution support for benefit-risk management of assigned products.
• Contribute to responses to health authority, institutional review board, and ethics committee queries.
• Support the development of safety risk language, risk management strategies, safety table shells, and integrated safety reviews.
• Contribute to integrated safety summary documents and safety-focused publications.
• Lead epidemiology and pharmacoepidemiology projects relevant to drug safety and pharmacovigilance, including natural history, comorbidities, class effects, real-world safety, signal detection, data mining, and comparative safety research.
• Collaborate with the Medical Review Lead and other physicians to establish consistent approaches to medical review, safety presentations, and surveillance activities.
• Assist with the development and maintenance of pharmacovigilance processes, SOPs, work instructions, safety management plans, and surveillance plans.
• Identify and implement process improvements across medical review, safety surveillance, and relevant pharmacovigilance activities.
• Ensure assigned activities meet applicable global regulatory requirements and standards for quality, accuracy, and timeliness.
• Perform additional drug safety and cross-functional responsibilities as needed.

Requirements:

The ideal candidate brings strong medical and pharmacovigilance expertise, with experience supporting clinical development programs in the biotechnology or pharmaceutical industry. Success in this role requires sound scientific judgment, strong analytical capabilities, and the ability to collaborate and influence effectively across multidisciplinary teams and regulatory environments.

• MD or equivalent medical degree.
• 6+ years of relevant clinical development drug safety or medical review experience within the biotechnology or pharmaceutical industry.
• Experience with medical review of ICSRs and periodic safety reports.
• Experience with late-stage or clinical development programs.
• Working proficiency with the Argus global safety database and medical review activities.
• Experience in safety surveillance and signal detection.
• Strong knowledge of global pharmacovigilance regulations and requirements, including FDA and EMA expectations.
• Experience with oncology, biologics, or innovative therapeutic modalities is valuable.
• 2–3 years of medical device safety experience is strongly preferred.
• Degree or substantial working knowledge in epidemiology or pharmacoepidemiology is highly preferred, such as an MPH, MS in Epidemiology, PhD in Epidemiology, or DrPH.
• Ability to interpret complex safety data and translate findings into actionable drug development strategies.
• Strong analytical, critical-thinking, and problem-solving skills.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to motivate teams and collaborate effectively across functional disciplines.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities while maintaining quality, accuracy, and deadlines.
• Ability to work effectively in a remote environment while participating in frequent in-person meetings and collaborative discussions.

Benefits:

• Salary: $280,000–$311,000 annual base salary, with actual compensation determined by factors including experience, education, skills, and geographic location.
• Bonus: Performance-based bonus opportunity.
• Equity: Equity grant opportunities.
• Healthcare: Health and welfare benefits.
• Retirement: Retirement benefits.
• Paid Time Off: Unlimited PTO.
• Company Breaks: Two one-week company-wide shutdowns each year.
• Work Model: Remote working environment.
• Collaboration: Frequent in-person meetings focused on solving complex problems and strengthening professional relationships.
• Professional Development: Opportunities to expand expertise and develop professionally.
• Scientific Impact: Opportunity to contribute to the safety strategy and development of innovative therapies.
• Leadership Scope: Broad exposure to medical safety, pharmacovigilance, regulatory strategy, clinical development, and benefit-risk management.