Job Description

Right to Care is currently seeking Pharmacists for Medicines Registration and Pharmacovigilance roles in Pretoria. These professionals will collaborate with the South African Health Products Regulatory Authority (SAHPRA) to carry out the specified responsibilities:Individual Case Safety Reports Management

• Processing of adverse drug events reports.
• Clinical case assessment of adverse drug reaction reports and feedback provision to reporters.
• Signal detection and management.
• Reporter follow-up and system update.

Benefit-Risk Assessment

• Investigate and review medicines safety concerns and prepare review reports for peer review and/or Pharmacovigilance Technical Advisory Committee discussions.
• Peer review technical reports
• Technical support to the Pharmacovigilance Technical Advisory Committee
• Publication of safety regulatory decisions made by the Authority.

Medicine Safety Communication

• Draft, finalise and communicate safety communication documents (DHCPL, Newsletter, Articles, MSAs, Media Queries, Press release) as per the guiding principles.

PV Stakeholder Management

• PV stakeholder management
• Arrange/participate in the stakeholder engagements.
• Record/Minute the discussions and action plans.
• Ensure implementation and follow-up of resolutions.

Promote PV Awareness and Outreach

• Develop a quarterly PV awareness and outreach plan.
• Develop/update PV training materials.
• Train healthcare professionals and the public on pharmacovigilance
• Coordinate medicine safety webinars.

Development And Maintenance of Guiding Principles (Sops, Guidelines, Policies, Etc.) To Ensure Consistency, Efficiency, And Alignment of PV Processes

• Identify and implement new approaches to improve and maintain high levels of operational efficiency and effectiveness.
• Update policy documents in line with international standards to improve and maintain high levels of operational efficiency and effectiveness.
• Development and maintenance of guiding principles (SOPs, guidelines, policies, etc.) to ensure consistency, efficiency and alignment of PV processes.

Minimum Qualification and Experience

• Matric certificate
• Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA.
• Proficient in MS Office.
• A valid Drivers License
• Minimum of three (3) to Five (5) years' experience in regulatory.
• Experience in drafting stakeholder communications and articles.
• Knowledge and application of the Medicines and Related Substances Act (Act 101 of 1965)
• Knowledge of quality, safety and efficacy aspects of medicine.

Desired Qualification and Experience

• A postgraduate qualification in relevant Pharmacy field

Right To Care