Global PV Operations Director

MapLight Therapeutics, Inc.; United States; On-site; USD 205,000 - 240,000; Full time

Benefits offered by this job

Annual bonus opportunity

Medical

Dental

Vision

Life and AD&D

Disability insurance

401(K) with match

Stock options

Flexible paid time off

Parental leave

Job summary

MapLight Therapeutics, Inc. is seeking a Director of Pharmacovigilance (PV) Operations in the United States to lead safety data management, PV strategy, and outsourced PV activities. You will oversee global case processing, aggregate reporting, and vendor oversight across clinical programs.

The role requires extensive PV leadership experience, regulatory knowledge, and strong cross-functional collaboration to drive compliance and strategic safety decisions.

Qualifications

• Health care professional degree or advanced degree in biomedical sciences or related field.
• Post-graduate business or project management training preferred.

Responsibilities

• Lead PV operations strategy, planning and execution.
• Provide global PV operations leadership including case management and aggregate reporting.
• Oversee CV safety system implementation for ICSR processing.
• Oversee PV vendor and contract management (CROs, partners).
• Manage safety data flow between clinical and PV vendors and QA processes.
• Maintain PV SOPs, forms, and SMPs; support audits/inspections.
• Collaborate with quality and cross-functional teams on safety deliverables.
• Project-manage PV functional deliverables and TMF contributions.
• Oversee PV budget, headcount, and vendor relationships.

Skills

PV leadership

Global vendor management

Regulatory reporting

Strategic thinking

Cross-functional collaboration

Pharmacovigilance experience

Education

Healthcare degree

MBA or PMP (preferred)

Job description

MapLight Therapeutics, Inc. is seeking a Director of Pharmacovigilance (PV) Operations in the United States to lead safety data management, PV strategy, and outsourced PV activities. You will oversee global case processing, aggregate reporting, and vendor oversight across clinical programs.

The role requires extensive PV leadership experience, regulatory knowledge, and strong cross-functional collaboration to drive compliance and strategic safety decisions.