Senior Director/VP, Pharmacovigilance (PV)

About Us: Apnimed is a rapidly growing pharmaceutical company focused on transforming the treatment of sleep apnea through innovative, patient-friendly therapies. Our approach is rooted in a simple idea: patients with obstructive sleep apnea may benefit from a safe, effective oral medication taken once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to help maintain an open airway during sleep. Based in Cambridge, Massachusetts, Apnimed is advancing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders through cutting-edge science and a commitment to innovation. Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees, and our mission, to thrive. Position Overview: The Head of Pharmacovigilance (PV) will build and lead Apnimed’s U.S focused pharmacovigilance function, ensuring the highest standards of patient safety, regulatory compliance and inspection readiness as the company transitions from clinical development to commercialization. This is a highly visible, hands-on leadership role responsible for establishing a scalable, fit-for-purpose PV infrastructure to support both ongoing clinical development and post-marketing activities. The ideal candidate brings deep experience in NDA-stage readiness and the implementation of post-marketing safety systems, including ICSR processing, aggregate reporting, signal detection, and vendor oversight. Key Responsibilities: Strategic Leadership

• Develop and execute Apnimed’s pharmacovigilance strategy aligned with regulatory requirements and company growth objectives
• Serve as the primary point of contact for safety-related interactions with regulatory authorities, including the FDA
• Provide strategic safety input for labeling updates, safety sections of regulatory submissions, including right-to-operate documents, and health authority responses

PV System Build & Oversight

• Establish and oversee a fit-for-purpose pharmacovigilance system spanning both clinical and post-marketing activities
• Design and implement PV SOPs, work instructions and vendor oversight models
• Ensure pharmacovigilance inspection and audit readiness across all PV activities

Safety Surveillance & Risk Management

• Oversee signal detection, risk assessment, and benefit-risk evaluation
• Lead development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), (if required)
• Ensure timely, accurate, and compliant safety reporting (e.g., PSURs/PBRERs, DSURs, NDA Annual Reports)

Cross-Functional Collaboration

• Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Commercial and Quality teams
• Provide safety input into clinical trial design, post-marketing studies and lifecycle management strategy

Vendor & Partner Management

• Oversee CROs and external safety vendors to ensure high-quality, compliant deliverables
• Establish effective governance frameworks, performance metrics, and oversight processes
• Own pharmacovigilance budget planning and resource strategy

Team Leadership

• Build, mentor, and lead a high-performing pharmacovigilance team
• Foster a culture of compliance, accountability, and continuous improvement

Qualifications:

• MD, PharmD, or PhD in a relevant discipline (advanced clinical training preferred)
• 10–15+ years of pharmacovigilance experience in biotech or pharma
• Proven leadership experience, including building or scaling PV functions
• Deep knowledge of FDA regulations and ICH pharmacovigilance guidelines (GCP and GVP)
• Direct experience supporting NDA reviews and product launches
• Strong understanding of safety databases, PV systems (e.g., Argus, ArisG) and outsourced vendor models
• Experience in respiratory, neurology, or sleep disorders is a plus
• Prior experience leading PV functions in a start‑up or small biotech environment is highly desirable

Key Competencies:

• Strategic thinker with hands-on execution ability in a fast-paced environment
• Deep expertise in regulatory compliance and inspection readiness
• Excellent communication and cross-functional leadership skills
• Ability to thrive in ambiguity and scale systems ahead of growth
• Proven experience with design and set up for an outsourced PV vendor and post-marketing product support

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Generous Company paid benefits
• Flexible working environment
• Motivated and experienced team

Location and Other Information:

• Apnimed is a privately held company based in Cambridge, MA
• 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

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