Director, Global Patient Safety Sciences - General Medicine (Pharmacovigilance)

Location: Tarrytown, NY or Warren, NJ; 4 days per week on site

Salary: $205,000–$341,600 annually

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Lead global patient safety activities for assigned compounds and products across surveillance, signal management, benefit-risk assessment, and safety communication.
• Develop safety strategies and oversee safety responses to regulatory agency questions and preparation of DSURs, PSURs, development RMPs, and RMPs.
• Lead cross-functional Safety Monitoring Team activities and represent Global Patient Safety on strategic, oversight, and independent data monitoring committees.
• Review clinical documents, including Investigator Brochures, protocols, and clinical study reports.
• Provide medical review support for complex individual case safety reports and other safety data sources.
• Mentor safety scientists, improve working practices, and collaborate with internal stakeholders, alliance partners, and CROs.

Requirements

• Onsite presence in Tarrytown, NY or Warren, NJ is required 4 days per week.
• 10+ years of relevant pharmacovigilance, medical, drug safety, or clinical development experience, including significant experience with PSURs, DSURs, and risk management plans.
• PharmD, PhD, or MD with 5+ years of relevant pharmacovigilance or medical experience.
• Experience leading and developing diverse safety professionals in a constructive, goal-oriented environment.
• Ability to apply FDA, EU, and ICH guidelines and regulations governing clinical trial and post-marketing pharmacovigilance.
• Ability to use a global patient safety database for medical case review and simple queries.

Nice to have

• Clinical or industry experience in oncology.

Culture & Benefits

• Science-driven environment focused on developing medicines for serious diseases.
• Opportunity to contribute to drug development, operations, and commercialization across global territories.
• Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, health insurance, paid time off, and family support benefits.
• Inclusive workplace with reasonable accommodation available during the recruitment process where required.