Senior Director, Global Medical Safety, Global Pharmacovigilance – Psychedelics

🕒 June 29

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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 • Develops and leads global safety strategy for late-stage psychedelic development portfolio • Develops safety monitoring approach for psychedelic class • Partners with GCD, CM and GRA to define appropriate therapist/guide escalation procedures • Chairs product level safety governance cross-functional meetings • Provides strategic regulatory safety leadership and authors safety content for Phase 2/3 protocols • Represents Global Safety in regulatory interactions • Manages the continuous analysis of adverse events to identify signals and trends • Participates in the creation and revisioning of SOPs

🎯 Requirements

• MD degree (required) with US medical license (preferred) • Demonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry • Strong medical background evidenced by clinical training • Proven track record of innovation in Medical Safety strategy, implementation and execution • Proven strategic resource management experience • Knowledge of FDA and global PV regulations • Experience in preparing and reviewing safety content for global regulatory filings (IND/NDA/MAA) • Experience interacting with global regulatory authorities

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits