Senior Manager, Pharmacovigilance Operations
Jazz Pharmaceuticals
12 hours ago
Remote friendly (California, United States)
United States
Operations
If you are a current Jazz employee, please apply via the Internal Career site.
Brief Description
Senior Manager, Pharmacovigilance (PV) Operations provides operational leadership and leads execution of global PV activities across clinical trial and post‑marketing programs, ensuring compliant, high‑quality, inspection‑ready PV operations.
Responsibilities
- Lead global PV operational activities (clinical trial and post‑marketing).
- Drive PV operational readiness for global launches and new market expansions.
- Act as PV Operations SME and provide operational guidance.
- Monitor PV operations for compliance, consistency, and inspection readiness.
- Manage safety reporting across the portfolio, including device-related events (SADEs, malfunctions) and MDR/IVDR compliance.
- Provide functional leadership to vendors/CROs/partners.
- Monitor and apply regulatory intelligence; translate into scalable safety database and operational solutions.
- Lead safety database (Argus) configuration, workflow validation, UAT, and impact assessments.
- Oversee outsourced case management and vendor performance; reconcile discrepancies.
- Lead compliance monitoring; support investigations, CAPA, and continuous improvement.
- Create/review training and SOPs/work instructions; prepare for audits/inspections.
Required Skills/Qualifications
- PV experience (clinical trial and post‑marketing) and global Argus safety database configuration/maintenance.
- Knowledge of global PV regulations and ICSR reporting requirements.
- Experience supporting global launches/country expansions and outsourced PV models.
- Hands-on safety systems/E2B reporting and workflow validation/UAT.
- Analytical, strong written/verbal communication; independent management in a matrixed/remote environment.
- Experience with medical device/combination product safety reporting (SADEs, malfunctions) and US MDR/EU IVDR.
Education
- Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline (required).
- Advanced degree/healthcare qualification (e.g., Pharm.D., RN/BSN/MSN) preferred.
Benefits/Compensation (US candidates)
- Base pay range: $141,600.00–$212,400.00; eligible for bonus/incentive, equity, and benefits (medical/dental/vision, 401k, flexible paid vacation).
Brief Description
Senior Manager, Pharmacovigilance (PV) Operations provides operational leadership and leads execution of global PV activities across clinical trial and post‑marketing programs, ensuring compliant, high‑quality, inspection‑ready PV operations.
Responsibilities
- Lead global PV operational activities (clinical trial and post‑marketing).
- Drive PV operational readiness for global launches and new market expansions.
- Act as PV Operations SME and provide operational guidance.
- Monitor PV operations for compliance, consistency, and inspection readiness.
- Manage safety reporting across the portfolio, including device-related events (SADEs, malfunctions) and MDR/IVDR compliance.
- Provide functional leadership to vendors/CROs/partners.
- Monitor and apply regulatory intelligence; translate into scalable safety database and operational solutions.
- Lead safety database (Argus) configuration, workflow validation, UAT, and impact assessments.
- Oversee outsourced case management and vendor performance; reconcile discrepancies.
- Lead compliance monitoring; support investigations, CAPA, and continuous improvement.
- Create/review training and SOPs/work instructions; prepare for audits/inspections.
Required Skills/Qualifications
- PV experience (clinical trial and post‑marketing) and global Argus safety database configuration/maintenance.
- Knowledge of global PV regulations and ICSR reporting requirements.
- Experience supporting global launches/country expansions and outsourced PV models.
- Hands-on safety systems/E2B reporting and workflow validation/UAT.
- Analytical, strong written/verbal communication; independent management in a matrixed/remote environment.
- Experience with medical device/combination product safety reporting (SADEs, malfunctions) and US MDR/EU IVDR.
Education
- Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline (required).
- Advanced degree/healthcare qualification (e.g., Pharm.D., RN/BSN/MSN) preferred.
Benefits/Compensation (US candidates)
- Base pay range: $141,600.00–$212,400.00; eligible for bonus/incentive, equity, and benefits (medical/dental/vision, 401k, flexible paid vacation).