This role requires a proactive approach to quality management and training, ensuring the highest standards of pharmacovigilance are met. The ideal candidate will be a guardian of product safety, a leader in educational initiatives, and a communicator of critical safety information for Southern Africa and East African countries. The individual must be able to support business requirements.Quality Management System:Uphold a quality assurance system compliant with GxP, ICH and Pharmacovigilance guidelines.Maintain and train staff on internal SOPs, ensuring alignment with company processes.Provide SOPs during audits and share audit findings to improve product safety.Report on ADRs and submit reports to the Health Authority when required.Perform monthly reconciliations.Training:Develop and lead training initiatives around Pharmacovigilance Safety.Participate in Servier Global Company training sessions.Conduct local PV training for new employees and annual refresher courses.Document and archive training details, making them available for inspections or audits.Pharmacovigilance System Master File (PSMF):Report audit findings and compile responses.Incorporate pharmacovigilance language in contracts managing safety data, aligning with Servier standards.Maintain and update the PSMF for all regions required.Audit Scheduling:Ensure the planning and scheduling of audits for Service Providers managing Pharmacovigilance activities for the Products.Regulatory Compliance:Ensure that Health Authorities in countries where Servier holds the Marketing Authorisation are notified of changes in pharmacovigilance management in compliance with local regulations.Regularly review and adhere to all relevant regulatory requirements.Compile safety updates for clinical submissions.Promptly report any compliance deficiencies to all concerned parties.Support Pharmacovigilance activities.Health Authority Inspections:Activities related to the Products may be subject to inspection by Health Authorities, and the Pharmacovigilance (PV) officer must inform management of any scheduled inspections.Corrective and Preventive Actions:Recommendations should be made for the business to implement corrective and preventive actions identified during audits or inspections that affect the organization's management of Pharmacovigilance.Monitor the implementation of corrective and preventive actions for the management of Pharmacovigilance activities highlighted during audits or inspections.Archiving Procedures:Securely store and archive all pharmacovigilance data locally and globally on the Servier databases.Retain personal data for the duration of the marketing authorization and ten years post-expiration, unless extended by national law.Maintain health data indefinitely, subject to national legislation.Archive documents according to Servier's established procedures.Safety Data and Case Processing: Individual Case Safety Reports (ICSRs)Process all safety information (ICSRs) as per Servier's training and quality documentation.Ensure data entry of ICSRs into the Argus LAM system is accurate and timely.Diligently work to clear ongoing and backlog cases, seeking additional information where necessary.Document follow-up actions and deviations from standard processes.Compile regular compliance reports to track case processing metrics and KPIs.Process Individual Case Safety Reports (ICSRs) efficiently, ensuring all cases undergo medical review and are submitted to Health Authorities within the specified timelines.Conduct thorough quality checks for weekly, monthly, quarterly, and bi-annual reconciliations with both internal and external stakeholders.Regularly update and review Product Information to align with the Company Core Data Sheets and complete other designated tasks.Prepare comprehensive aggregate safety reports, such as PSURs, PBRERs, and Addendum Safety Reports, as required.Develop and maintain Risk Management Systems, including Risk Management Plans and Risk Communication Plans.Handle Requests for Information (RFIs) from Competent Regulatory Authorities (CRAs) and manage Safety Communications, including Dear Healthcare Professional Letters (DHCPLs).Respond promptly and comprehensively to safety-related inquiries from regulatory agencies and Servier Affiliates.Stay vigilant in monitoring local literature for designated products to identify safety issues or ICSRs promptly.Create and keep Safety Data Exchange Agreements (SDEAs) up to date, ensuring clear communication and obligations are met between partners.EDUCATION & EXPERIENCEB. Pharm is a requirement.1-3 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety.KNOWLEDGEStrong knowledge of regulatory and medical authorities in Southern Africa and East Africa.Strong understanding of regulations, ICH and Pharmacovigilance guidelines.Extensive medical writing and expertise in submissions.At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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