Pharmacovigilance Pharmacist

Overview: We are seeking a Pharmacovigilance Pharmacist to oversee product safety and regulatory compliance across Southern and East Africa. The role involves maintaining quality systems, training staff, and managing safety data. Key Responsibilities: Quality Management: Ensure adherence to GxP, ICH, and pharmacovigilance guidelines. Train staff on SOPs, provide SOPs during audits, report ADRs, and conduct monthly reconciliations. Training: Develop and lead pharmacovigilance training programs, conduct local training for new hires and annual refreshers, and document training for audits. Pharmacovigilance System Master File (PSMF): Update the PSMF, report audit findings, and manage pharmacovigilance language in contracts. Audit Scheduling: Plan and schedule audits for service providers handling pharmacovigilance. Regulatory Compliance: Notify Health Authorities of changes, review and adhere to regulatory requirements, compile safety updates, and address compliance issues. Health Authority Inspections: Notify management of scheduled inspections related to products. Corrective and Preventive Actions: Recommend and oversee implementation of corrective actions from audits or inspections. Archiving: Store and archive pharmacovigilance data locally and globally, retain personal and health data as per legislation. Safety Data Processing: Process Individual Case Safety Reports (ICSRs), manage safety data, prepare reports, and handle Safety Communications. Education & Experience: Degree: Bachelor of Pharmacy (B. Pharm). Experience: 1-3 years in pharmacovigilance or drug safety. Knowledge: Understanding of regulatory authorities and guidelines in Southern and East Africa. Knowledge of regulations, ICH guidelines, and Good Clinical Practice (GCP). Proficiency in medical writing and submissions.

Location: Johannesburg, ZA

Posted Date: 10/5/2024