Global Pharmacovigilance Operations Director

MapLight Therapeutics; Burlington (MA); On-site; USD 205,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Medical/Dental/Vision

Stock options

401(k) with match

Parental leave

Paid time off

Job summary

MapLight Therapeutics seeks a Director, Pharmacovigilance Operations to lead safety data management, strategy, and external partner activities across programs. You will shape the company’s PV governance, oversee ICSR processing, and drive vendor relations while ensuring compliance with global PV regulations.

The role requires deep PV expertise, leadership experience in biopharma, and the ability to collaborate across Clinical Operations, QA, and regulatory teams.

Qualifications

• Experience with global PV regulations, GVP and ICH guidelines.
• Proven ability to manage ICSR case processing and safety reporting.
• Experience with safety systems, MedDRA, and drug coding reviews.

Responsibilities

• Lead strategy, planning, and maintenance of safety databases and PV activities.
• Oversee case management, vendor oversight, and aggregate reporting.
• Implement PV safety system for regulatory compliant ICSR processing.
• Oversee PV vendor contracts and alliance safety management.
• Coordinate data flow between clinical and PV vendors with Clinical Ops.
• Ensure quality and compliance for ICSR processing and KPI reporting.
• Develop and maintain SOPs, forms, and safety documents.
• Collaborate with QA for audits/inspections and TMF contributions.
• Budget PV operations and mentor PV associates.
• Lead cross-functional safety deliverables and safety communications.

Skills

PV operations leadership

Safety data review

Vendor management

Strategy development

Global regulatory knowledge

Cross-functional collaboration

Audit & inspection readiness

Education

Health care professional degree (RN/BSN/PharmD) or advanced degree in biomedical sciences

Post-graduate management training (MBA/PMP)

Job description

MapLight Therapeutics seeks a Director, Pharmacovigilance Operations to lead safety data management, strategy, and external partner activities across programs. You will shape the company’s PV governance, oversee ICSR processing, and drive vendor relations while ensuring compliance with global PV regulations.

The role requires deep PV expertise, leadership experience in biopharma, and the ability to collaborate across Clinical Operations, QA, and regulatory teams.