Position: Pharmacovigilance Pharmacist
Salary: Market related
Location: Midrand
Job type: Permanent
Industry: Pharmaceutical
Reference Number: RDT.S.PP.13082024
COMPANY DESCRIPTION:
Our client is an international pharmaceutical company with offices in Midrand and they are looking for a Pharmacovigilance Pharmacist to join their team as soon as possible.
JOB DESCRIPTION:
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.
MAIN DUTIES & RESPONSIBILITIES:
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 in Pharmacovigilance Safety.
- Participate in 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 Company 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 Company 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’s 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 Company 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 Company’s established procedures.
Safety Data and Case Processing: Individual Case Safety Reports (ICSRs):
- Process all safety information (ICSRs) as per Company’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 Company 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.
EDUCATIONAL REQUIREMENTS:
- Grade 12
- B. Pharm is a requirement
EXPERIENCE AND SKILLS REQUIRED:
- 1 – 3 Years’ pharmaceutical experience with specific focus areas in PV/Drug Safety
- Strong knowledge of regulatory and medical authorities in Southern Africa and East Africa
- Strong understanding of regulations, ICH guidelines, and GCP
- Extensive medical writing and expertise in submissions
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