Director, Safety Scientist
$187,000–$281,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead the scientific evaluation and management of safety risks across assigned programs, driving proactive, data-informed strategies in partnership with Medical Directors. Oversee delivery of safety science activities, ensuring robust benefit–risk assessments and consistency in scientific execution. Lead and develop a team of Safety Scientists, fostering rigor and accountability while managing vendor relationships and cross-functional alignment. Author and review critical clinical documents including protocols, Investigator's Brochures, and aggregate safety reports for global regulatory submission. Represent global patient safety at regulatory inspections and shape governance discussions that inform key decision-making. Manage portfolio goals aligned to strategy and ensure compliance with PV regulations for assigned assets.
Required Qualifications
- Advanced degree in a biologic/medical/clinical/nursing field
- At least 7+ years' experience in drug safety/pharmacovigilance within the pharmaceutical industry or biotech
- Subject matter expertise in global pharmacovigilance regulations
- Experience with: Preparing aggregate safety reports and conducting signal surveillance clinical development including risk/benefit analysis and safety assessment
- Risk management and minimization programs
- Proven skill set for strategic leadership in a cross functional matrix
- Strong analytical, problem solving, and scientific writing skills
- Demonstrated learning agility and ability to work independently
- Sound, independent judgement based on knowledge and expertise
- Advanced project leadership with strong organizational and prioritization skills
- Strong personal time-management and project-management skills
- Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
- Understanding of downstream regulatory, patient, business, and reputational impact of PV actions
Desired Qualifications
- Expertise with clinical and safety databases
- Experience in MedDRA coding and search strategies
- Experience with data visualization tools (e.g., Power BI, Spotfire)
- Experience with various roles in drug safety (e.g., case processing, operations)
- Mastery of Microsoft Word, PowerPoint and Excel
- Pharmacist/PharmD
- Nurse Practitioner
- PhD
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