Director, Safety Risk Management Scientist
$219,606–$268,408 year
On-site · Cambridge, Massachusetts, United States
Job Summary
Experienced safety surveillance and risk management scientist with a degree in life sciences and 10+ years’ experience. Performs proactive safety monitoring and signal detection for assigned products, authors signal assessment reports, and develops safety monitoring and pharmacovigilance plans. Manages cross-functional safety management teams; authors/Reviews safety sections for regulatory submissions (DSUR, BLA/MAA) and related CRO documents. Oversees periodic reports collaboration with external vendors; contributes to development and revision of PV SOPs. Collaborates with PV Operations, medical affairs, R&D, clinical operations, data management, biostatistics, regulatory, quality, and manufacturing. Demonstrates excellent verbal and written communication, organizational, and analytical skills; proficient with MS Office Suite.
Required Qualifications
- Degree in life sciences (Pharmacy, Nursing or MS in health-related field)
- 10+ years of experience in safety surveillance and safety risk management
- Deep understanding of FDA and EU-GVP guidance on safety signal management, periodic report development, safety risk management and benefit-risk assessment
- Excellent verbal and written communication skills
- Strong organizational and analytical abilities
- Proficiency with Microsoft Office Suite
- Ability to collaborate with PV Operation team and cross-functional stakeholders
- Experience drafting and reviewing safety sections/documents for regulatory submissions (DSUR, BLA/MAA)
- Experience with safety monitoring plans, pharmacovigilance plans, and CRO oversight
- Experience participating in PV audits and inspections
- Advanced degree in epidemiology (desired)
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