Director, Pharmacovigilance Operations

Director, Pharmacovigilance Operations

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

The Director, Pharmacovigilance (PV) Operations will lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities through partners and contract research organizations. Reporting to the Vice President, Pharmacovigilance, this person will oversee the collection, evaluation, and reporting of safety data from clinical trials, shaping the company's safety governance framework and supporting strategic decisions related to PV operations across programs.

Responsibilities :

• Develop strategy for PV operations and support PV Head in the implementation of strategy and vision for PV function
• Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Manage the implementation of MPLT safety system (safety database and process) for regulatory compliant ICSR case processing
• Oversight of PV vendor and contract management (e.g. third party CRO, partners)
• Oversight of alliance management related to safety (SDEAs)
• Manage flow of information and data between clinical and PV vendor in collaboration with Clinical operation (e.g. PV mailbox)
• Oversight of quality and compliance for ICSR case processing and reporting (KPI)
• Develop, contribute, review and maintain up to date ICSR case processing SOPs, forms, SMPs etc.
• Liaise with safety surveillance and cross-functional teams to support for timely dissemination of safety deliverables
• Collaborate with Quality function and lead PV contributions for audit and inspections
• Project management for PV functional deliverables
• Oversight of PV functional contributions to TMFs
• Manage PV budget and resources for PV vendor
• Coach and mentor PV operation associates

We consider these behaviors we seek in all ML employees.

Qualifications :

Location : This is a hybrid position with onsite at our office in Burlington, MA.

Travel : Ability to travel as needed (up to 10%) for corporate and departmental meetings.

Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation / benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

Salary Range $205,000 - $240,000 USD