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Jobs or company...

Global Compliance Lead

Salary undisclosed

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Currently I have an opening for a Global Compliance Lead (PV Audits & Inspection Readiness), Remote. Details for the position are as follows:

Job Description:

  • Supports pharmacovigilance audits and inspection-related activities within Global Patient Safety Evaluation (PSPV) for assigned audits/inspections, under the guidance and oversight of the reporting manager.
  • Manages day-to-day activities related to audits and inspections readiness within PSPV.
  • Serves as the primary representative within PSPV for the preparation and coordination of audits and inspections and liaises with the responsible PSPV Subject Matter Experts to ensure that audits and inspections requests are appropriately and timely fulfilled.
  • Coordinates and manages the development and review of responses to PSPV audit findings and inspections.
  • Reviews audit and inspections responses to requests to ensure quality and adequacy prior to providing to QA for final QC. Coordinates and contributes to strategic discussions, as needed.
  • Collaborates with other inspection management leads outside of PSPV and quality/compliance/inspection readiness colleagues for activities related to audits and inspection preparation.
  • Interfaces and collaborates with various stakeholders including but not limited to the PSPV Subject Matter Experts (SMEs), PSPV PV Affiliates Management (PV-AM), PSPV Compliance vendors, and R&D QA, pre-, during, and post- audits and inspections, to support preparation activities, fulfillment of audits and inspection requests for PSPV, and responses to observations.
  • Supports compliance-related activities, as needed such as the coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs), and the monitoring of PSPV compliance metrics.
  • Maintains current knowledge of relevant PV regulations, including evolving changes in the regulations that may impact compliance.
  • Bachelor of Science degree in medical or science related field; post-graduate degree or equivalent a plus.
  • Experience in the pharmaceutical industry with at least 4 years of relevant experience in pharmacovigilance compliance and audits and inspections.
  • Knowledge of FDA/EU regulations, and ICH guidelines for GVP and GCP with practical experience in the interpretation and implementation of PV regulations. Ability to interpret PV regulations, analyse gaps, and identify opportunities for improvement within PSPV.
  • Experience with quality management systems (e.g., Trackwise) a plus!

Technical Information:

  • Pay: $90-120 hourly, depending on experience level
  • Remote, EST hours
  • 6-month contract, potential for extension
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