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Director / Senior Director, Pharmacovigilance Operations

10 hours, 46 minutes ago
United States
Full-time
Executive
Operations Manager
Operations
Apply Now
Rezolute Bio

Rezolute Bio

Rezolute Bio is focused on developing advanced therapies for metabolic diseases, specifically targeting conditions such as congenital hyperinsulinism and diabetic macular edema through clinical trials.

Pharmaceuticals
51-200
$312M raised
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Description

  • Develop and execute pharmacovigilance strategy for late-stage development, regulatory submissions, product launch, and post-marketing surveillance.
  • Build a scalable, inspection-ready PV operating model, including people, processes, systems, governance, and external partnerships.
  • Lead commercial launch-readiness activities, including adverse-event intake, case processing, reconciliation, vendor interfaces, escalation pathways, and business continuity.
  • Oversee safety surveillance, signal detection and management, benefit-risk assessments, aggregate reports, risk management plans, and risk-minimization activities.
  • Provide oversight of adverse-event case management, including ICSR collection, assessment, follow-up, quality review, and regulatory submission.
  • Manage PV vendors, safety systems, outsourced operations, performance metrics, and internal-versus-outsourced capability planning.
  • Establish and maintain PV quality systems, SOPs, work instructions, CAPA processes, compliance monitoring, and inspection readiness.
  • Partner with Clinical, Regulatory, Medical Affairs, Quality, Commercial, Legal, and other functions on safety, labeling, launch, and regulatory activities.
  • Develop and oversee SDEAs and PV provisions with partners, including case exchange, reporting, reconciliation, safety governance, and compliance monitoring.
  • Represent Pharmacovigilance in governance forums, safety committees, regulatory inspections, audits, and health authority interactions.

Requirements

  • Advanced degree in health or life sciences, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training preferred; candidates with a bachelor’s or master’s degree plus significant PV leadership experience may be considered.
  • Director candidates typically need 10+ years of pharmaceutical or biotechnology experience, including about 7+ years in pharmacovigilance or drug safety.
  • Senior Director candidates typically need 12–15+ years of pharmaceutical or biotechnology experience with progressive PV leadership responsibility.
  • Experience supporting late-stage clinical development and/or marketed products.
  • Experience managing outsourced PV operations, vendors, and safety database providers.
  • Demonstrated knowledge of global PV regulations and requirements from FDA, EMA, ICH, and other health authorities.
  • Strong expertise in ICSR management, expedited reporting, signal management, aggregate reporting, benefit-risk assessment, risk management, safety governance, and PV quality systems.
  • Experience leading PV activities through regulatory approval and commercial launch, particularly for Senior Director candidates.
  • Experience establishing or scaling a PV function and a clinical-to-commercial PV operating model, ideally in a small or mid-sized biotechnology company.
  • Experience with Oracle Argus Safety or an equivalent validated safety database is desirable; experience with NDA/BLA/MAA submissions, inspections, rare disease, oncology, biologics, and product launches is preferred.

Benefits

  • Base salary range of $255,000–$315,000, depending on location, qualifications, education, and experience.
  • Eligibility for an annual performance bonus.
  • Medical, dental, and vision insurance.
  • Disability, life, and long-term care insurance.
  • Holiday pay and a tracking-free vacation program.
  • 401(k) plan match.
  • Educational assistance benefit.
  • Fitness center reimbursement.

Interested in this position?

Apply directly on the company website

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