Pharmacovigilance Pharmacist

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