Director, Pharmacovigilance Operations (Fully Remote)

MapLight Therapeutics; United States; Remote; USD 205,000 - 240,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D

401(k) match

Stock options

Flexible PTO

Parental leave

Job summary

MapLight Therapeutics is a clinical stage biotech company focused on CNS drug discovery, seeking a seasoned Pharmacovigilance leader to oversee safety data management, regulatory reporting, and PV governance in a fast-paced setting.

The role leads safety databases, coordinates with CROs, and drives lifecycle safety deliverables across programs, ensuring inspection readiness and global compliance. Requires 8+ years PV experience with leadership background.

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.

Responsibilities

• 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.
• 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.

Skills

PV leadership

Global regulatory knowledge

Safety systems

Vendor management

Education

Healthcare professional degree

Advanced degree in biomedical/pharmaceutical sciences

Job description

• 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.