PV Pharmacist 30 views

Purpose:

A French pharmaceutical company is seeking a PV Pharmacist who has 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, a communicator of critical safety information for Southern Africa and East African countries and must be able to support business requirements

Key Job Outputs:

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 around pharmacovigilance safety
• Participate in 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 the 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 organisation’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 authorisation and ten years post-expiration, unless extended by national law
• Maintain health data indefinitely, subject to national legislation
• Archive documents according to the company’s established procedures

Safety data and case processing: Individual Case Safety Reports (ICSRs)

• Process all safety information (ICSRs) as per company 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

Qualifications:

• Pharm

Experience:

• 1-3 yrs. 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

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013