Director, Pharmacovigilance

Summary:

The Director, Pharmacovigilance will support the development and execution of Apnimed’s pharmacovigilance and drug safety strategy as the company prepares for commercialization and continues clinical development.

Reporting to the Vice President, Pharmacovigilance, this role will drive day-to-day execution and provide hands-on oversight across post-marketing pharmacovigilance, safety operations, vendor oversight, compliance, safety surveillance, aggregate reporting, and inspection readiness.

This role will work cross-functionally with Medical Affairs, Regulatory Affairs, Quality, Commercial, Medical Information, and external service providers to ensure an effective, compliant, and inspection-ready pharmacovigilance system.

Key Responsibilities:

• Support implementation and ongoing management of the company’s pharmacovigilance processes and infrastructure
• Provide oversight of PV vendors and delegated PV activities including vendor performance, quality, compliance, metrics, and issue resolution
• Support development and maintenance of PV SOPs, safety management plans, safety data exchange agreements (SDEAs), and other controlled documents
• Support U.S. commercial launch readiness, including integration of safety reporting pathways across Medical Information, pharmacies, distributors, patient support programs, and other third parties
• Lead reconciliation activities across relevant safety data sources and business partners
• Support preparation and review of periodic and aggregate safety reports, including PADERs and other required reports
• Participate in signal detection, tracking, and safety governance activities
• Support clinical safety activities for ongoing and future studies, including SAE oversight, reconciliation, and vendor management
• Maintain inspection readiness of PV processes and documentation and support audits, inspections, and CAPAs
• Develop and deliver PV training to cross-functional teams and external partners
• Additional duties as assigned by management.

Qualifications

• Bachelor’s degree in nursing, pharmacy, life sciences, or related healthcare/scientific discipline required; advanced degree preferred
• 8 years of relevant pharmacovigilance/drug safety experience including hands-on post-marketing PV experience
• Experience within a biotechnology or pharmaceutical sponsor organization strongly preferred; U.S. commercial launch experience a plus
• Demonstrated experience with vendor oversight, case management, aggregate reporting, PVA/SDEA, and PV compliance
• Experience supporting clinical development safety activities
• Strong knowledge of U.S. and global pharmacovigilance regulations, FDA post-marketing safety reporting requirements, and applicable ICH guidelines
• Experience with PV metrics, quality systems, and audit/inspection readiness
• Strong organizational, analytical, problem-solving, and project-management skills
• Ability to operate effectively in a fast-paced, evolving biotechnology environment; capable of independently managing multiple priorities and escalating issues appropriately

What Apnimed Offers:

• 401(k) with companymatch
• Generous time off for vacation
• Generous healthcare benefits
• Flexible working environment
• Motivated and experienced team
• Winner of 2024 Boston Business Journal Best Places to Work

Location and Other Information:

• Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical
• We are a small growing Company with an inclusive environment
• Must be able to travel as necessary
• Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment
• Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea