This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Pharmacovigilance based in the United States.
In this role, you will lead pharmacovigilance operations across clinical-stage programs within a fast-evolving biotech environment focused on advancing innovative immunotherapy solutions. You will be responsible for ensuring the integrity, compliance, and effectiveness of global safety systems that support the development of next-generation therapies. The position plays a critical role in shaping safety strategy, overseeing case processing, and enabling high-quality regulatory submissions across multiple jurisdictions. You will work closely with Clinical Development, Regulatory Affairs, Medical Affairs, and external vendors to ensure robust safety surveillance and inspection readiness. This is both a strategic and hands-on leadership role where operational excellence and scientific rigor are essential. You will also contribute to building scalable PV infrastructure to support future organizational growth. The environment is highly collaborative, mission-driven, and centered on delivering transformative outcomes for patients.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Pharmacovigilance based in the United States.
In this role, you will lead pharmacovigilance operations across clinical-stage programs within a fast-evolving biotech environment focused on advancing innovative immunotherapy solutions. You will be responsible for ensuring the integrity, compliance, and effectiveness of global safety systems that support the development of next-generation therapies. The position plays a critical role in shaping safety strategy, overseeing case processing, and enabling high-quality regulatory submissions across multiple jurisdictions. You will work closely with Clinical Development, Regulatory Affairs, Medical Affairs, and external vendors to ensure robust safety surveillance and inspection readiness. This is both a strategic and hands-on leadership role where operational excellence and scientific rigor are essential. You will also contribute to building scalable PV infrastructure to support future organizational growth. The environment is highly collaborative, mission-driven, and centered on delivering transformative outcomes for patients.
Accountabilities:
- Oversee end-to-day pharmacovigilance operations including case intake, triage, medical review support, and expedited safety reporting in compliance with global regulations
- Ensure adherence to FDA, EMA, and ICH pharmacovigilance requirements across all clinical programs
- Manage PV vendors and CRO partnerships, ensuring high-quality service delivery, data accuracy, and regulatory compliance
- Lead preparation and review of aggregate safety reports including DSURs, PSURs/PBRERs, IND safety reports, and related regulatory submissions
- Support development and maintenance of SOPs, safety databases, and Pharmacovigilance System Master File documentation
- Drive signal detection activities, safety data review, trend analysis, and participation in risk management planning
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, and Medical Affairs to ensure aligned safety strategies
- Ensure inspection readiness through audit support, internal quality oversight, and continuous process improvement initiatives
- Contribute to strategic planning and scaling of pharmacovigilance systems and infrastructure
- Advanced degree in a health-related field (MD, PharmD, PhD, MS, RN, NP, or PA) with 10+ years of pharmacovigilance experience in biotech or pharmaceutical environments
- Strong expertise in global pharmacovigilance regulations (FDA, EMA, ICH) and safety reporting requirements
- Proven experience managing outsourced PV models, including oversight of CROs and external vendors
- Hands-on experience with safety databases, case processing workflows, and aggregate reporting processes
- Background in clinical-stage drug development, preferably in oncology, cell therapy, or gene therapy
- Strong analytical and problem-solving skills with the ability to interpret safety data and identify risks
- Excellent communication skills and ability to collaborate across scientific, regulatory, and operational teams
- Experience ensuring inspection readiness and supporting regulatory audits or health authority inspections
- Strong leadership mindset with the ability to operate effectively in a fast-paced, evolving biotech environment
- Competitive salary range of $204,000 – $305,000 USD depending on experience and location
- Comprehensive medical, dental, and vision insurance plans
- 401(k) retirement plan with company matching contributions
- Generous paid time off policy and flexible work arrangements
- Employee commuter benefits and cell phone stipend
- Opportunities to work on cutting-edge immunotherapy programs with high patient impact
- Collaborative and mission-driven work environment focused on innovation and scientific excellence