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Salary: USD 205,000 - 240,000 / annual
MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders, combining optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop therapies for psychiatric symptoms.
The Director, Pharmacovigilance Operations will lead the strategy, planning, execution, and maintenance of safety databases and outsourced pharmacovigilance activities through partners and contract research organizations. Reporting to the Vice President of Pharmacovigilance, this role oversees the collection, evaluation, and reporting of safety data from clinical trials while shaping the company's safety governance framework and supporting strategic decisions related to PV operations across programs.
Key responsibilities include developing PV operations strategy and supporting the PV Head in implementing the PV function vision; providing strategic leadership for global pharmacovigilance operations including case management, vendor oversight, and aggregate reporting; managing implementation of the company's safety system for regulatory-compliant ICSR case processing; overseeing PV vendor and contract management with third-party CROs and partners; managing alliance-related safety oversight; coordinating information flow between clinical and PV vendors in collaboration with clinical operations; ensuring quality and compliance for ICSR case processing and reporting; developing and maintaining ICSR case processing SOPs, forms, and safety management plans; liaising with safety surveillance and cross-functional teams for timely safety deliverables; collaborating with Quality on audits and inspections; managing PV functional deliverables and project management; overseeing PV contributions to trial master files; managing PV budget and vendor resources; and coaching and mentoring PV operation associates.
This is a hybrid position based in Burlington, MA, with up to 10% travel for corporate and departmental meetings.
QUALIFICATIONS:
- Healthcare professional degree (RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science. Preferred: post-graduate training in business management or project management (MBA, PMP).
- Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years leading PV operations. Preferred: experience in neuroscience, psychiatry, or neurodegenerative disease area.
- Competence in conducting 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 in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.
- Demonstrated PV project management skills in a fast-paced organization.
- Exceptional communication and cross-functional collaboration skills.
- Strategic thinker able to translate complex safety data into actionable insights for regulatory and clinical decision-making.
- Ability to work within a growing organization and help it evolve; ability to engage in open, constructive, continuous dialogue with stakeholders based on equality and mutual respect.
- Highly motivated, self-driven, and dependable.
