Senior Director, Patient Safety & Pharmacovigilance

Location: San Francisco, Thousand Oaks, or Washington, DC, United States; hybrid

Company

hirify.global is a biotherapeutics company developing a portfolio of clinical-stage and post-marketing programs.

What you will do

• Lead safety surveillance, signal detection and management, risk management, and benefit-risk assessments across development and post-marketing programs.
• Oversee global aggregate safety reporting, including DSURs, PSURs/PBRERs, PADERs, risk management plans, investigator’s brochures, study reports, and regulatory safety submissions.
• Direct end-to-end pharmacovigilance operations, including case processing, medical review, regulatory reporting, and safety data exchange.
• Provide strategic oversight of validated PV systems, data integrity, technology adoption, and scalable process design.
• Manage PV vendors, CROs, and service providers while leading governance, performance, compliance, and inspection-readiness activities.
• Serve as the patient safety and pharmacovigilance subject-matter expert, presenting safety assessments to leadership, investigators, DSMBs/DMCs, and regulatory authorities.

Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, public health, or a related scientific discipline.
• 10+ years of experience in patient safety, pharmacovigilance, safety science, or related pharmaceutical or biotech functions.
• Experience supporting clinical-stage drug development and knowledge of global PV requirements from IND through commercialization.
• Expertise in safety surveillance, signal management, aggregate safety analysis, benefit-risk assessment, and global ICSR reporting.
• Experience with key safety documents, outsourced PV operations, regulatory inspections, and compliant PV processes and systems.
• Proficiency with PV databases and tools such as Argus, and with MedDRA and WHO Drug dictionaries.

Nice to have

• Advanced degree such as PharmD, PhD, MD, MPH, or MS.
• Experience supporting NDA and/or MAA submissions.
• Experience in pain therapeutics or neuroscience.

Culture & Benefits

• Cross-functional collaboration across clinical, regulatory, scientific, and development functions.
• Opportunity to shape a scalable pharmacovigilance operating model supporting portfolio growth, geographic expansion, submissions, and commercialization.
• Hybrid work arrangement in San Francisco, Thousand Oaks, or Washington, DC.