Senior Director, Drug Safety and Pharmacovigilance Operations
Company: Ladders Agency
- Location: United States
- Work mode: Remote
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
For our client, we are seeking a Senior Director, Drug Safety and Pharmacovigilance Operations to join the team of a leader in the Pharmaceuticals & Biotech space.
This leader will guide the operational strategy for global drug safety and pharmacovigilance activities, with a strong emphasis on case processing, expedited reporting, and inspection readiness. The role partners closely with internal stakeholders, vendors, and external partners to ensure compliant, efficient safety operations across clinical programs. This leader will also help shape scalable workflows, performance metrics, and governance practices that support the advancement of important medicines.
Location: Remote
Compensation: $295,000 – $312,000 annually
Responsibilities
- Oversee end-to-end case processing for clinical safety information
- Serve as the subject matter expert for the global safety database
- Manage expedited safety reporting to ensure regulatory compliance
- Establish workflows and monitor KPIs for case processing activities
- Ensure compliance by monitoring safety operations of vendors and partners
- Lead vendor governance and operational oversight for DSPV activities
- Coordinate and maintain readiness for audits and inspections
Qualifications
- Master's degree in life sciences or equivalent; nursing (RN) or pharmacy (PharmD) preferred
- 8+ years of experience in pharmacovigilance operations within the biotech or pharmaceutical industry
- Hands-on experience with global safety databases, particularly Argus
- Proficiency in case processing, safety database oversight, vendor governance, and compliance readiness
- Strong understanding of ICH guidelines and U.S. and European pharmacovigilance regulations
- Experience preparing safety data outputs for aggregate reports, including DSUR and 6MLLs
- Excellent analytical, problem-solving, and communication skills
Benefits
- Dynamic work environment with the opportunity to shape company culture and advance medicines
- Comprehensive benefits package including performance bonuses and equity opportunities
- Unlimited paid time off (PTO) for work-life balance
- Two company-wide shutdowns each year for rest
- Professional development opportunities for career growth
- Remote working flexibility with in-person meetings for collaboration
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.
