Director, Pharmacovigilance Operations

MapLight Therapeutics•Burlington, MA

1d•$205,000 - $240,000•Hybrid

About The Position

MapLight Therapeutics is a clinical-stage biotechnology company focused on drug discovery for central nervous system disorders, using technologies such as optogenetics, in vivo physiology, and spatial transcriptomics. The Director, Pharmacovigilance Operations will lead strategy, planning, execution, and maintenance of safety databases and outsourced pharmacovigilance activities conducted through partners and contract research organizations. Reporting to the Vice President, Pharmacovigilance, this role oversees the collection, evaluation, and reporting of clinical-trial safety data, helps shape the company’s safety governance framework, and supports strategic decisions about PV operations across programs. This is a hybrid position based onsite at the company’s office in Burlington, Massachusetts. Travel may be required for corporate and departmental meetings, up to 10%.

Requirements

Health care professional degree (e.g., RN, BSN, or PharmD), or an advanced degree (Master’s or PhD) in biomedical sciences, pharmaceutical sciences, or a related life science.
At least 8 years of pharmacovigilance experience in the biopharmaceutical industry, including at least 3 years leading PV operations.
Competence in safety data reviews, vendor management, preparation of aggregate reports, signal detection, and risk management plans for investigational and/or post-marketed products.
Experience with MedDRA and drug-coding reviews.
Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug-development processes.
Experience with PV processes for individual case handling, signal management, aggregate data review and reporting, and audits and inspections.
Demonstrated PV project-management skills in a fast-paced organization.
Exceptional communication and cross-functional collaboration skills.
Strategic thinking and ability to translate complex safety data into actionable insights for regulatory and clinical decision-making.
Ability to work in a growing organization and help it evolve.
Ability to engage in open, constructive, and continuous dialogue with company stakeholders based on equality and mutual respect.
Highly motivated, self-driven, and dependable.
Commitment to MapLight’s Core Beliefs and Values.

Nice To Haves

Post-graduate training in business management or project management, such as an MBA or PMP.
Experience in neuroscience, psychiatry, or neurodegenerative disease.

Responsibilities

Develop PV operations strategy and support the PV Head in implementing the PV function’s strategy and vision.
Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
Manage implementation of the MPLT safety system, including the safety database and processes for regulatory-compliant ICSR case processing.
Oversee PV vendor and contract management, including third-party CROs and partners.
Oversee safety-related alliance management, including safety data exchange agreements (SDEAs).
Manage information and data flow between Clinical and PV vendors in collaboration with Clinical Operations, including the PV mailbox.
Oversee quality and compliance for ICSR case processing and reporting, including KPIs.
Develop, contribute to, review, and maintain current ICSR case-processing SOPs, forms, SMPs, and related materials.
Liaise with safety surveillance and cross-functional teams to support timely dissemination of safety deliverables.
Collaborate with the Quality function and lead PV contributions to audits and inspections.
Manage PV functional deliverables as projects.
Oversee PV functional contributions to TMFs.
Manage the PV vendor budget and resources.
Coach and mentor PV operations associates.