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

Location: Remote for individuals hired to perform the role in the United States; approximately 20% travel and occasional after-hours meetings with Japan required.

Salary: $249,973–$388,125 annually, plus incentive opportunity.

Company

hirify.global is a pharmaceutical company developing and commercializing medicines, including a late-stage psychedelic portfolio.

What you will do

• Lead global medical safety strategy for approximately four late-stage psychedelic assets from development through commercialization.
• Define safety monitoring for altered states of consciousness, perceptual disturbances, emotional dysregulation, prolonged psychological effects, and related risks.
• Develop benefit-risk frameworks, psychological safety standards, therapist or guide escalation procedures, and emergency intervention frameworks.
• Analyze adverse events, identify safety signals and trends, and make medical decisions for risk management plans, safety reports, and core data sheets.
• Author and review safety content for Phase 2/3 protocols, INDs, NDAs, MAAs, investigator brochures, clinical study reports, and other regulatory submissions.
• Represent Global Safety in governance meetings, regulatory interactions, inspections, and audits while mentoring safety professionals.

Requirements

• MD degree and strong clinical training; a US medical license is preferred.
• At least 10 years of experience as a safety or pharmacovigilance professional in the pharmaceutical industry.
• Strong knowledge of FDA and global pharmacovigilance regulations, clinical trials, Good Clinical Practice, ICH guidelines, signal detection, and risk management.
• Experience preparing and reviewing safety content for global regulatory filings and interacting with global regulatory authorities.
• Ability to lead in ambiguous, evolving scientific and regulatory environments, make decisions, influence without authority, and collaborate cross-functionally.
• Ability to work across therapeutic areas and functions while managing multiple high-priority initiatives.

Nice to have

• Clinical trial experience with psychedelic-assisted therapy.
• Knowledge of controlled-substance regulations and DEA requirements.
• Experience with suicidality monitoring tools such as C-SSRS and abuse-liability monitoring.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life and disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Global cross-functional collaboration with opportunities to mentor and develop colleagues.