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Director, Pharmacovigilance Operations (Fully Remote)

L7

maplight therapeuticsDenver, CO3 days ago

$205,000 - $240,000

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. 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.
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Level

ManagerL7

Salary

$205,000 - $240,000

Location

Denver, CO

Occupation

Regulatory Affairs Managers

Industry

Pharmaceutical Preparation Manufacturing

Posted

3 days ago

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