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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.