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Pharmacovigilance job at ClinGroup

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Overview

We are a French-initiated group of companies holding 5 major know-how covering the health sector R&D services with 18 successful years of European-American excellence and expertise. We have expanded in Southern & Eastern Europe, Africa, Middle East & Central Asia continues
 and developed over 400 success stories and over 50 partnerships and alliances. Our areas of excellence include mainly: -Clinical Research, Monitoring & Project Management. -Logistics & Regulatory Affairs Management -Quality Control & Assurance, Coaching & Auditing. -Clinical Information Technology, Writing, Data Management (& e-DM), Statistics.  -Continuing Education, Training & Development.

About the job

  • Act as PV contact point with corresponding local authorities on 24-hour basis, when required;
  • Have an overview of medicinal product safety profiles and any emerging safety concerns;
  • Create and maintain PSMF/PSSF;
  • Maintain awareness of Pharmacovigilance regulatory requirements and developments;
  • Perform weekly scientific literature screening and report identified ADRs;
  • Identify, collect and report adverse events (ICSRs);
  • Conduct all internal required trainings as per training plan;
  • Conduct all required trainings by clients;
  • Assist in the creation of project plans for each assigned project;
  • Follow-up on QPPV(s)/Deputies duties and responsibilities;
  • Create and adapt SOPs as required per project;
  • Perform periodic QC on all reports drafted by the QPPV(s)/Deputy QPPV(s);
  • Read and acknowledge all necessary company standard operating procedures (SOPs) and customer SOPs as required;
  • Report nonconformities as per Quality SOPs, and complete CAPA forms when needed.

    • CLICK HERE TO APPLY

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    2 years ago
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