Global PV Audit & Inspection Management Specialist (S424)

  • Contract Duration: Through 2021, with potential to extend
  • Clinical
  • Bridgewater, NJ

Website Lenox Executive Search

DESCRIPTION:

Contract role through 2021 with potential to extend. Will begin Remote and transition to 50% onsite in Bridgewater, NJ once it is safe to do so.

Lenox Executive Search is seeking an experienced Global PV Audit & Inspection Management Specialist to fill an 6+ month contractual role with a global pharmaceutical company in Bridgewater, NJ. Must have 2-3 years experience in the field of Pharmacovigilance (PV) or clinical inspections as well as experience with audits and/or inspection management.

REQUIREMENTS:

  • Bachelor’s or higher in Pharmacy (BS, RPh, Pharm D) or Bachelor’s or higher in nursing (BSN, BScN) or biological science discipline (Biology, Health Sciences…).
  • 2 to 3 Years Experience
  • Experience in pharmacovigilance and in the field of PV or clinical inspections.
  • Experience with audits and/or inspection management
  • Ability to interact with inspectorates from Health Authorities in a constructive manner.
  • Excellent knowledge of International (ICH/CIOMS), EU (Good PV practices) and FDA regulations in the domain of Pharmacovigilance.
  • Knowledge of MS Office suite
  • Ability to work in transversal/cross functional teams.
  • Excellent communication skills (oral and written).
  • Excellent organizational and planning capabilities.
  • Knowledge of International (ICH/CIOMS), EU (Good PV practices) and FDA regulations in the domain of Pharmacovigilance.
  • Capability to work under extreme pressure.

RESPONSIBILITIES:

  • Ensure that MAHs/Sponsors audit and/or inspection readiness comply with the business partner agreement and/or regulatory obligations, specific to pharmacovigilance. To support preparation, conduct and follow-up of business partner, internal and/or regulatory inspection impacting PV until closure.
  • Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits or Business
  • Partner audits impacting global PV processes, until closure.
  • Ensure completion of audit/inspections PV related Corrective and Preventive Actions (CAPAs) to ensure timely completion and effectiveness to prevent recurrence.
  • Participating in the ongoing permanent inspection preparedness and readiness of GPE and country PV offices in anticipation of Regulatory inspections and audits.
  • Active involvement in the preparation, conduct and follow-up of regulatory inspections impacting PV until closure.
  • Support external relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV regulations in the field of PV inspections and benchmark on recurrent PV findings.
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