Senior Executive Director, Pharmacovigilance
New
J
Jade BiosciencesBiotechnology
Location: RemoteFull-TimeExecutive
Salary250,000 - 330,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 10-15 years of industry experience with a minimum of 10 years of pharmacovigilance/drug safety experience
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor’s degree and 10-15 years of industry experience.
- Minimum 10 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry.
- Progressive leadership responsibility, with head-of-function experience required for the Executive Director level.
- Proven experience building fit-for-purpose PV processes and quality systems in a development-stage company.
- Deep working knowledge of global PV regulations (21 CFR, ICH E2A/E2B/E2C/E2D/E2F, EU GVP modules).
- Track record of successful PV vendor selection and safety database (e.g., Argus) management.
- Experience managing outsourced case processing operations.
- Demonstrated success supporting FDA/EMA health authority inspections and sponsor audits.
- Excellent scientific judgment and written/verbal communication skills.
- Experience with biologics/monoclonal antibodies and immunology/nephrology programs preferred.
- Experience supporting late-stage global development and BLA/MAA deliverables preferred.
Responsibilities
- Ensure timely and compliant expedited and periodic safety reporting to global health authorities.
- Author or provide senior review of safety content for protocols, Investigator's Brochures, and clinical study reports.
- Provide strategic and operational oversight of outsourced PV service providers and safety databases.
- Manage PV budget, vendor performance, KPIs, and safety data exchange agreements (SDEAs).
- Build and maintain a PV quality system including SOPs, work instructions, and the PV system master file.
- Lead PV inspection- and audit-readiness activities to ensure GVP/GCP compliance.
- Partner with clinical, regulatory, and biometric teams to represent PV strategy.
- Hire, mentor, and develop PV staff and consultants as the organization scales.
View Full Description & ApplyYou'll be redirected to the employer's site
