Pharmacovigilance Pharmacist/Deputy National Safety Officer - Johannesburg at Unique Personnel

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
• Inherent Requirements    

Qualification:

• Bachelor of Pharmacy

Experience and Skills:

• Experience in Pharmacovigilance in a pharmaceutical company 
• PSMF and PSUR compilations 
• MS Office incl. Co-Pilot 
• Operating in a high pressurized environment 
• Operating with minimal degree of supervision 
• Organized and detail orientated