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Salary: USD 220,000 - 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, Safety Scientist, Pharmacovigilance will lead high-quality safety surveillance activities for assigned products, ensuring compliance with global regulations. This role bridges pharmacovigilance, clinical teams, and regulatory functions to proactively manage drug safety throughout the product lifecycle.
Key responsibilities include:
- Managing safety surveillance and signal detection activities, including periodic reviews of aggregate safety data and safety surveillance team meetings
- Representing pharmacovigilance at clinical study teams for assigned products
- Developing signal assessment reports under oversight of the Program Safety Lead for validated safety signals
- Collaborating with PV operations on timely and accurate medical review of individual case safety reports (ICSRs)
- Developing and contributing to safety risk management plans across the product lifecycle
- Developing and managing periodic reports (DSUR/PBRER)
- Contributing to data analysis and authoring safety sections for regulatory submissions and responses
- Contributing to development or updates of safety surveillance and risk management SOPs and templates
- Collaborating with clinical study teams on safety surveillance deliverables (Investigator's Brochure, Randomization Safety Information, protocols, briefing documents)
- Participating in pharmacovigilance audits and inspections
- Representing the pharmacovigilance function in internal and external committees and activities as appropriate
The role requires strong cross-functional collaboration, exceptional interpersonal skills, and demonstrated leadership in mentoring and supporting team members. The successful candidate will be a strategic thinker who can translate complex safety data into actionable insights for regulatory and clinical decision-making, while thriving in a growing organization.
Travel up to 10% for corporate and departmental meetings is required.
QUALIFICATIONS:
- Healthcare professional degree (RN, BSN, PharmD) or advanced degree (Master's/PhD) in biomedical sciences, pharmaceutical sciences, or related life science. Preferred: post-graduate training in epidemiology (MPH).
- Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience. Preferred: safety surveillance and risk management experience in neuroscience, psychiatry, or neurodegenerative disease.
- Competence in conducting safety data reviews, 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 pharmacovigilance regulations, Good Vigilance Practices (GVP), ICH guidelines, safety systems, and drug development processes.
- Experience in pharmacovigilance processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.
- Exceptional communication and cross-functional collaboration skills.
- Strategic thinking with ability 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 over time.
- Ability to engage in open, constructive, and continuous dialogue with stakeholders based on equality and mutual respect.
- Highly motivated, self-driven, and dependable.
- Commitment to MapLight's core beliefs and values.
