Vice President, Pharmacovigilance

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do: MapLight is looking for a dynamic and experienced Vice President, Pharmacovigilance to manage and oversee the company's drug safety activities. Reporting to the Chief Medical Officer (CMO) the Vice President, Pharmacovigilance will design and develop MapLight’s Drug Safety and Pharmacovigilance function; implementing safety surveillance programs and risk management activities to ensure the safety and efficacy of our neurological and psychiatric therapies throughout their lifecycle.

This senior leadership position requires a strategic thinker with extensive experience in pharmacovigilance, regulatory compliance, and risk management. The successful candidate will collaborate closely with cross-functional stakeholders to uphold the highest standards of drug safety and regulatory compliance.

Responsibilities:

• Develop and execute a strategic vision for the Pharmacovigilance department, aligning with the company's objectives and industry best practices.
• Provide subject matter expertise to internal stakeholders and ensure compliance with global pharmacovigilance regulations and guidelines.
• Eventually lead and mentor a team of pharmacovigilance professionals, fostering a culture of collaboration, excellence, and continuous improvement.
• Oversee the collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, and other relevant sources.
• Lead the preparation and submission of expedited and periodic safety reports to health authorities, ensuring accuracy, completeness, and timeliness.
• Develop and implement risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies), to minimize potential safety risks.
• Lead signal detection activities to identify potential safety signals by analyzing safety data from various sources, including clinical trials, investigator-initiated trials, compassionate use programs, comparable products, and real-world evidence.
• Conduct comprehensive benefit-risk assessments to inform decision-making and regulatory interactions.
• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other departments to ensure effective communication of safety information and alignment on safety strategies.
• Provide pharmacovigilance expertise in regulatory interactions, including Health Authority meetings and audits.
• Ensure compliance with global pharmacovigilance regulations and guidelines, and drive the development and maintenance of pharmacovigilance SOPs and processes.
• Lead pharmacovigilance audits and inspections, ensuring timely and accurate responses to regulatory inquiries.
• Prepare and submit high-quality safety reports, including periodic safety reports (PSURs/PBRERs), development safety update reports (DSURs), and ad-hoc safety communications to regulatory authorities.
• Develop and define SOPs and departmental procedures and ensures the uniform and timely processing of adverse event reports.

Qualifications:

• Medical Doctorate (M.D.) degree or equivalent.
• Relevant therapeutic experience in an academic or hospital environment in Neurology/Psychiatry preferred.
• 10+ years of Pharmacovigilance experience, with at least 5 years in a leadership/management role with a thorough understanding of Drug Safety department dynamics
• Excellent clinical judgment, strong organizational abilities, high credibility and significant leadership potential
• Experience supervising the drug safety processes from development to implementation.
• Experience with regulatory agencies and knowledge of ICH and GCP regulations and prior experience with Drug Safety databases.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
• Ability to work in a fast-paced, early-stage biotechnology environment, adapting to changing priorities and demands.

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.