Director, Pharmacovigilance Operations
Benefits
Unlimited PTO
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Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)
PrimeVigilance
Europe
Pharmacovigilance
Regulatory Affairs
Communication
What You'll Do:
- Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
- Oversee collection, evaluation, and reporting of safety data from clinical trials.
- Support the VP of Pharmacovigilance in shaping the company's safety governance framework.
Responsibilities:
- Manage the implementation of the MPLT safety system for regulatory compliant ICSR case processing.
- Oversee PV vendor and contract management, including third-party CROs and partners.
- Collaborate with clinical operations and quality functions to ensure timely safety deliverables and inspection readiness.
Qualifications:
- Health care professional degree or advanced degree in biomedical or pharmaceutical sciences.
- Minimum 8 years of pharmacovigilance experience with at least 3 years leading PV operations.
- Demonstrated expertise in global PV regulations, GVP/ICH guidelines, and safety systems.
Compensation & Benefits:
- Salary range $205,000 - $240,000 USD plus annual bonus opportunity.
- Medical, dental, vision, life and AD&D, short and long term disability, 401(k) match, stock options.
- Flexible non-accrual paid time off and parental leave.
MapLight Therapeutics
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.