Pharmacovigilance Pharmacist/Deputy National Safety Officer

Main Purpose of Job:
The role is responsible for the management and co-ordination of all PV activities of all products sold by the Company within South Africa and export countries. Compliance with local regulations regarding PV activities and ensuring compliance with all Global PV requirements
Key Performance Areas:
ADR Management:
Collection of ADR reports from all sources, logging of ADRs into the Global system, investigation, follow up and closure of ADRs
Timely reporting of ADRs to local regulatory authority (SAHPRA) as per local and Global requirements
Evaluation of reported ADRs, assessing impact on local market and taking appropriate action in consultation with NSO as required
Evaluation of medical queries escalating to ADRs if required
Pharmacovigilance System:
Implement and maintain a PV system in accordance with local regulatory requirements and global requirements
Liaise with Global and regional PV colleagues on daily, monthly, and annual KPI
Implement corrective action and system changes as a result of Global, Regional or regulatory PV audits
Management of all PV, Risk, FSCA related SOPs
Evaluation and investigation of safety relevant medical queries received and providing appropriate customer feedback where applicable
Review of marketing material to assess any potential safety risks
Tracking of regulatory safety variations to ensure any PV requirements are considered and implemented with the safety variation
Compilation of PSURs for locally produced products as and when required
Compilation and completion of local and Global PV KPIs
Compilation and maintenance of local PSMF in accordance with local and Global requirements
Literature searches:
Maintenance of Service Level Agreement with external provider of literature searches
Assess weekly reports of literature searches to identify any potential ADRs
Compiling monthly statistical reports of literature searches to determine if any action needs to be taken
Reporting of all potential signals to Global PV for action if required
Training on Pharmacovigilance:
Ensure all new employees at the company are trained on the basics of Pharmacovigilance
Ensure that all current employees receive annual Refresher PV Training
Establish personal training plan and keep up to date with current PV training requirements
Deputy National Safety Officer:
Delegation as Deputy National Safety Officer
Attend expert circle meetings as Deputy NSO
Management of all reported Field Safety Action notices issued by Global PV to ensure these are sent to customers within required timeframe
Management of any local Field Safety Action notices required and to ensure they are received within the given timeframe by customers and assist in compilation of FSCA reports.
Assist with TPN release as per schedule and when required
Review of Marketing material for compliance as PV reviewer
Assist with Responsible Pharmacist and quality responsibilities as required
Pharmacovigilance Compliance:
Ensure that you receive a yearly mandatory Pharmacovigilance (PV) training.
Roles involving direct interaction with customers such as Sales Representatives, Customer Care, and Export functions to report any Adverse Drug Reactions (ADRs) complaints to the PV Compliance Officer within one business day of product complaint occurrence.
Export Country Distributors:
Establish and maintain Quality Agreements with export distributors
Conduct regular audits of Export distributors in accordance with annual audit plan and procedural requirements
Maintain CAPAs required from export distributors to ensure compliance with the company and Global requirements
Complaint Reporting and Processing:
Manage complaints process within the company
Ensure timeous submission and closure of complaints on gCMW
Review and evaluate complaints for safety relevance
Dispatch complaint samples to relevant investigators for complaint investigations
Follow up and monitor complaints received and logged onto gCMW
Review of completed complaint investigations to ensure information provided addresses the complaint
Ensure all customer correspondence is professional and accurate and in accordance with the complaint investigation
Complete monthly complaint KPI trend analysis
Proactively assess risks identified and safety relevant complaints through complaint trend analysis and take appropriate actions to mitigate risks to prevent occurrence of a non-conformity
Product Quality Reviews:
Compile and submit annual TPN PQR
Compile, maintain and update the summary PQR schedule for products (including export products).
Compile and submit summary PQRs products annually