Pharmacovigilance Pharmacist

at  Servier

Date posted: Aug 12, 2024
City: Midrand, Johannesburg
Country/Region: ZA
Type of Contract: Unlimited contract
Job Requisition ID: 6678
Pharmacovigilance Pharmacist
.
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.

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 & EXPERIENCE

• B. Pharm is a requirement.
• 1-3 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety.

KNOWLEDGE

• Strong 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
  Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit… All this and more in a workplace focused on your well-being.
  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.

Please refer the Job description for details