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Director/ Executive Director, Pv Qms Lead - Safety & Pharmacovigilance

10+ years
$184,000 to $239,000
10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: BSN/MSN/PhD/PharmD/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director/Executive Director, PV QMS Lead - Safety & Pharmacovigilance
Company: Ionis Pharmaceuticals
Location: Boston, MA, USA (Remote)

Summary:
The Director/Executive Director, PV QMS Lead is responsible for overseeing the Pharmacovigilance Quality Management System (QMS) globally, ensuring audit and inspection readiness. This role involves leading Compliance & Training within the Safety/PV team and cross-functionally to drive global compliance. The individual will provide strategic input and tactical implementation for Pharmacovigilance activities, identify compliance risks, oversee action plans, and develop corrective and preventative measures. This position reports to the VP and Head of Safety & PV.

Responsibilities:

  • Oversee global PV compliance and PV quality oversight for the QMS, including Deviations, CAPAs, and KPIs.
  • Support Global Quality teams with inspection activities, including mock interviews, SME identification, and post-inspection responses to regulatory authorities (FDA, EMA, MHRA, HPRA, Health Canada).
  • Collaborate with cross-functional teams, including Global Regulatory Compliance, Regulatory Affairs, Drug Development, Commercial, Market Research, and Legal.
  • Work with the QPPV and deputy QPPV to ensure compliance with regulatory requirements.
  • Oversee planning, execution, and delivery of CAPA strategies for quality events.
  • Lead internal audits and inspection-related CAPAs.
  • Conduct investigations of significant quality events, including issue identification, impact assessment, and root cause analysis.
  • Maintain expertise in US and international GCP/GLP/PV regulatory requirements and company SOPs.
  • Lead and ensure timely PV training.
  • Establish and monitor PV KPIs leveraging industry benchmarks.
  • Develop and maintain reporting metrics, dashboards, and scorecards for performance monitoring.

Requirements:

  • Master’s degree in life sciences (BSN, MSN, PhD, PharmD, Master’s in Health Law/Regulatory & Compliance, or BS in Life Sciences with 10+ years of experience).
  • At least 10 years of post-qualification experience.
  • Strong understanding of the pharmaceutical/biopharmaceutical industry, including clinical research, regulatory requirements, QA, and safety reporting.
  • Ability to work across therapeutic areas and functions.
  • Experience in project management (PMP certification is a plus).
  • Ability to manage multiple projects and prioritize tasks effectively.

Compensation & Benefits:

  • Salary range: $184,000 to $239,000.
  • Comprehensive benefits package (details available at Ionis Benefits).

Application Process:

  • Apply online at www.ionis.com (Reference Requisition #IONIS003541).
  • No phone calls, principals only.
  • Ionis Pharmaceuticals, Inc. is an Equal Employment Opportunity employer.