Global Medical Safety Director Psychedelic Pharmacovigilance

Otsuka America Pharmaceutical Inc.; Lansing (MI); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Comprehensive benefits

Generous 401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Medical Safety physician to lead safety strategy for late-stage psychedelic programs and ensure robust pharmacovigilance across development and commercialization.

This role demands deep clinical safety expertise, regulatory know-how, and the ability to navigate complex regulatory landscapes while partnering with Global PV, Clinical Development, and Regulatory Affairs.

Qualifications

• MD degree with US medical license required.
• Minimum 10 years in pharmaceutical safety/PV.
• Proven leadership in cross-functional teams.
• Experience with psychedelic development is preferred.

Responsibilities

• Serve as the medical safety expert for late-stage development through commercialization.
• Develop global safety strategy for psychedelic portfolio.
• Define safety monitoring approaches for psychedelic class.
• Prepare safety content for regulatory submissions.
• Lead cross-functional safety governance meetings.

Skills

Global PV leadership

Pharmacovigilance strategy

Safety risk management

Regulatory submissions (IND/NDA/MAA)

Medical safety expert

Education

MD degree with US medical license

10+ years PV experience

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Medical Safety physician to lead safety strategy for late-stage psychedelic programs and ensure robust pharmacovigilance across development and commercialization.

This role demands deep clinical safety expertise, regulatory know-how, and the ability to navigate complex regulatory landscapes while partnering with Global PV, Clinical Development, and Regulatory Affairs.