Director, Safety Scientist, Pharmacovigilance
The Director, Safety Scientist, Pharmacovigilance at MapLight Therapeutics will lead safety surveillance activities, including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management for assigned products. This role involves collaboration with the Program Safety Lead, pharmacovigilance operations, and contract research organizations (CROs) to ensure proactive safety surveillance in compliance with global regulations.
Key responsibilities include managing safety surveillance and signal detection activities, representing pharmacovigilance at clinical study team meetings, developing signal assessment reports, collaborating with PV operations for timely and accurate medical review of ICSRs, developing and contributing to safety risk management plans across the product lifecycle, and participating in PV audits and inspections. The role also involves contributing to data analysis and authoring safety sections for regulatory submissions and responses.
The ideal candidate will possess a healthcare professional degree (e.g., RN, BSN, PharmD) or an advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or a related life science. A minimum of 10 years of pharmacovigilance experience within the biopharmaceutical industry, including at least 3 years of direct clinical or patient care experience, is required. Preferred qualifications include post-graduate training in epidemiology (e.g., MPH) and experience in safety surveillance and risk management in neuroscience, psychiatry, or neurodegenerative disease areas.
Compensation for this role ranges from $220,000 to $240,000 annually, with additional benefits including an annual bonus opportunity, medical, dental, vision, life and AD&D insurance, short-term and long-term disability coverage, a 401(k) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders. The company combines cutting-edge technologies, including optogenetics, in vivo physiology, and spatial transcriptomics, to identify novel drug targets and develop effective therapies to address psychiatric symptoms. Joining MapLight offers the opportunity to work in a dynamic environment dedicated to improving patient outcomes through innovative research and development.