Director, Drug Safety & Pharmacovigilance Operations
Director, Drug Safety & Pharmacovigilance Operations Salary: $210–230k Base (depending on experience) Location: Morristown, NJ Area – Hybrid onsite preferred Therapeutic Area: Oncology and Rare Disease We are partnered with a growing, commercial-stage biotech organization focused on advancing innovative therapies across multiple indications who is searching for a Director, Drug Safety & Pharmacovigilance (DSPV) Operations who will report to the VP of Development, Regulatory & Safety and works closely with the Senior Medical Director and Senior Director of Regulatory Affairs. This individual is responsible for leading all core pharmacovigilance operations, including case management, signal detection, safety systems, vendor oversight, and quality management. The role serves as the in-house subject matter expert for drug safety across both investigational and marketed products, with full oversight of PV activities to ensure compliance with global regulations, company policies, and procedures, while continuously monitoring and evaluating product safety profiles.
Responsibilities
- Oversee the compliance of all PV operations activities, identifying areas for improvement and deviations from process, and initiating/managing Corrective and Preventive Actions (CAPA), as required
- Provides oversight of all DSPV vendor activities, maintains effective communications with vendors, and serves as the point of contact for matters related to PV contract management
- Provides scientific and PV regulatory input into safety documents and relevant sections of regulatory documents such as clinical study reports, protocols, safety analysis, expert statements, submission dossiers, and health authority responses
- Supports the monitoring of the safety profile of products, including signal detection, evaluation of safety information, and management of signal evaluation activities and documentation
- Oversee the preparation of aggregate safety reports (DSUR, PADER, Safety section of IND and NDA Annual Reports), relevant sections of regulatory documents, and health authority responses
- Provides training on AE reporting to employees, contractors, and vendors
- Provide PV management and support to Business Partners, including management of PV
- Authors and maintains departmental SOPs, work instructions, guidance, associated forms, and templates
- Participates in regulatory inspections and audits, supports proactive inspection activities, maintains inspection readiness
- Participate in departmental budget planning and management
What We’re Looking For
- Degree in a healthcare or life sciences field (RN, BSN, PharmD, PA, NP, or similar)
- 5+ years of pharmacovigilance/drug safety for a biotech/pharmaceutical company in clinical trial and post-marketing environments with a thorough understanding of safety operations.
- Strong knowledge of FDA regulations, ICH guidelines, and global PV requirements
- Experience managing PV vendors and safety systems
Why This Opportunity
- Growing biotech with expanding pipeline and strong leadership
- High-visibility role with direct impact on safety strategy and operations
- Opportunity to build, optimize, and lead PV infrastructure
- Collaborative, cross-functional environment
- Competitive compensation and long-term growth potential
How To Apply We’d love to see your resume, but we don’t need it to have a conversation. Email [email protected] or message me directly if you’d like to learn more. #LI-TO1 #LI-HYBRID