Senior Director, Global Medical Safety, Global Pharmacovigilance (psychedelics)

About the role

The Senior Director, Global Medical Safety physician (psychedelics) leads and supports safety team(s) in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. This role provides proactive strategic and operational safety leadership for Otsuka's late-stage psychedelic development portfolio (~4 assets).

Responsibilities

• Serves as the medical safety expert for assigned products for late stage development through commercialization.
• Maintains accurate and complete knowledge of assigned investigational and marketed products, being monitored by Otsuka, co-marketers, cosponsors, and/or affiliates.
• Develops and leads global safety strategy for late-stage psychedelic development portfolio.
• Develops safety monitoring approach for psychedelic class, (eg acute altered states of consciousness, perceptual disturbances, emotional dysregulation, prolonged psychological effects, etc)
• Pairs with GCD, CM and GRA to define appropriate therapist/guide escalation procedures and emergency intervention frameworks.
• Develops integrated benefit-risk frameworks tailored to psychedelic-assisted therapies and novel neuropsychiatric mechanisms.
• Serves as the safety representative on asset strategy and governance teams (Product Development Committee (PDC) and Research & Development Teams (RDT)).
• Contributes to TrPP and overall development strategy.
• Establishes standards for psychological safety monitoring before, during and after dosing sessions.
• Chairs product level safety governance cross-functional meetings.
• Serves as the safety representative on asset strategy and governance teams (Product Development Committee (PDC) and Research & Development Teams (RDT)).
• Contributes to TrPP and overall development strategy.
• Establishes standards for psychological safety monitoring before, during and after dosing sessions.
• Chairs product level safety governance cross-functional meetings.
• Represents Global Safety in regulatory interactions; presenting and defending safety findings, emerging safety signals and benefit-risk evaluations, while providing clear scientific and clinical interpretation to enable regulatory decision making.
• Responsible for authoring safety surveillance plan and reviewing case report forms, investigator brochures, CSRs, package inserts, and NDA/PLA documents, including patient narratives.
• Responsible for medical analysis and assessing patient safety impact for product quality or other quality related events.
• Keeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication.
• Represents GPV CS&PV at Labeling Committee/ Executive Committee discussions on new information impacting product profile.
• Manages the continuous analysis of adverse events to identify signals and trends for assigned products.
• Performs review and approval of clinical trial medical coding.
• Participates in the creation and revisioning of SOPs.
• Provides strategic input on safety issues during development portfolio reviews and governance meetings.
• Prepares/review safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports.
• Provides medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, risk management plans (RMPs/REMS) and individual case safety reports.
• Serves as mentor and resource for GPV Associates, Scientists and Safety physicians.
• Participates in providing training to GPV team members and other Otsuka staff as appropriate, on the epidemiological and regulatory aspects of programs.
• Participates in inspection and audit readiness activities as medical safety subject matter expert.
• Utilizes technical/medical knowledge to assist GPV team members in the assessment of adverse event reports.
• Keeps abreast of current developments in the field and maintains knowledge base by attending seminars, professional association meetings, and maintaining industry and professional network.

Requirements

MD degree (required) with US medical license (preferred). Demonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry. Ability to act as in-house authority/leader in Global Pharmacovigilance; and be fully accountable for Safety of assigned products. High level of medical competence, with an ability to balance this with industry standards to achieve business goals. A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities. Able to work across therapeutic areas and functions. Works collaboratively (establishes shared purpose across boundaries). Develops people and the organization (invests in long-term development of others).