Senior Medical Director, Pharmacovigilance

Job Description: • Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products. • Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle. • Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products. • Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information • Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content. • Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses. • Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval. • Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents. • Perform the medical review of all adverse event reports for seriousness, expectedness and causality. • Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products. • Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate. Requirements: • MD or equivalent with 3-5 years of relevant clinical experience • Preferred: Board Certified/Board Eligible in Neurology or psychiatry • Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products • Preferred: experience in NDA/IND submissions in neuroscience, psychiatry or neurodegenerative therapeutic area • Proven experience in safety data analysis, signal management, and benefit-risk evaluation • Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar) • Demonstrated ability to develop and implement drug safety strategies and risk management plans • Proven experience with authoring or contributing to clinical study and regulatory submission documents • Working knowledge of relevant local and global regulatory requirements and guidance documents • Able to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment • Able to work within a growing organization and to help the organization evolve over time. • Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect. • Effective oral and written communication skills. • Highly motivated, self-driven and dependable. • Committed to MapLight's Core Beliefs and Values. Benefits: • annual bonus opportunity • medical insurance • dental insurance • vision insurance • life and AD&D insurance • short term disability • long term disability • 401(K) plan with match • stock options • flexible non-accrual paid time off • parental leave