Pharmacovigilance and Patient Safety Director

7 days ago


Morrisville, United States Lifelancer Full time

WEP Clinical is a global leader in clinical trial supplies, expanded access programs, and hospital supply of unlicensed medicines.

We are seeking an experienced Pharmacovigilance and Patient Safety Manager to join our team in the United States. The estimated salary for this role is $110,000 - $140,000 per year, depending on experience.

Job Description:

The Pharmacovigilance and Patient Safety Manager will be responsible for managing the safety profile of new drugs, devices, and interventions in clinical trials, as well as during the post-marketing phase and across various expanded access programs.

The ideal candidate will have a strong background in pharmacovigilance and patient safety, with experience in drug safety/pharmacovigilance roles in the biotech/pharmaceutical industry or CRO/clinical trial setting.

Key Responsibilities:
  • Monitor CRO/business partner activities to ensure adherence to Safety Monitoring Plans, study plans, KPIs, and contractual agreements
  • Serve as SME for PV compliance, inspection readiness, and safety management topics
  • Provide operational leadership for ICSR workflows and oversee case management in Argus or other safety databases
  • Ensure pharmacovigilance oversight for clinical trials, post-market surveillance, and Expanded Access Programs (EAPs)
  • Perform case triage, quality control, and adverse event coding using MedDRA and WHO drug
  • Author safety reports (e.g., CIOMS/MedWatch) and ensure compliance with regulatory timelines
  • Collaborate with stakeholders for safety database reconciliation and resolve discrepancies
  • Oversee global safety database administration, including vendor oversight, issue resolution, and training
  • Author/review Safety Management Plans, study forms, and periodic safety reports (e.g., DSUR, PSUR)
  • Support signal detection, evaluation activities, and provide safety content review for regulatory documents
Requirements:
  • Bachelor's Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
  • Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
  • Proficient with International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines and other applicable regulatory rules and guidelines, as well with medical terminology, clinical trials and clinical research
  • Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
  • Action-oriented and resilient in a fast-paced environment with strong project team skills and ability to mentor, delegate and motivate others
  • Ability to communicate effectively with clients, internal teams and vendors and soft skills to build and maintain trust and confidence
  • Strong understanding of global safety regulations, medical terminology, and drug development process
  • Strong clinical background, with ability to interpret medical records (e.g., laboratory results, medical records) is a plus
What We Offer:
  • Medical, dental, and vision insurance
  • Short-term disability insurance
  • Life insurance
  • Voluntary Long-term disability insurance
  • 401K safe harbor plan and company match
  • Paid vacation, holiday, sick, and volunteer time
  • Paid maternity & paternity leave
  • Personal Development Allowance


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