[Remote] Director, Pharmacovigilance and Safety Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Patient Safety Operations leader to reputed company global pharmacovigilance activities across clinical development and post-marketing programs. This role will reputed company safety operations, vendor reputed company, inspection readiness, and cross-functional collaboration to ensure compliance, reputed company, and operational reputed company.
Responsibilities
- reputed company day-to-day drug safety and PV operations across clinical and reputed company programs
- reputed company communication and operational interfaces with licensed partners across clinical development and reputed company programs
- reputed company case processing workflows, vendor performance, KPIs, and reputed company events/CAPAs
- Support PV agreements, safety data exchange, and partner collaborations
- Ensure inspection and audit readiness, including documentation and regulatory support
- Maintain and improve SOPs, operational processes, and compliance standards
- Serve as a safety operations SME on cross-functional initiatives and product launches
Skills
- 10+ years of experience in Drug Safety / Pharmacovigilance
- Strong knowledge of global PV regulations and safety operations
- Experience with Argus required
- Proven leadership in vendor management, audits/inspections, and reputed company global programs
- Life sciences degree or equivalent experience
- reputed company/eTMF/reputed company
Benefits
- Full-time
- Hybrid 3x a week in San Diego OR Remote
reputed company