Minimum Educational Qualifications required for the job
Pharmacist Assistant qualification.
Registered with South African Pharmacy Council (SAPC).
(Preferable BPharma)
Minimum years of Experience required for the job 2 years PVG

Position Summary:
To act as the Deputy Responsible Person for PVG during the absence of RPP of Africa. Also to assist the RPP of the region with development and maintenance of PV processes and systems.

Job Profile:

1. PHARMACOVIGILANCE

S. No. Area Description
1. Pharmacovigilance
• Act as a secondary Pharmacovigilance contact for Regulatory Authority (MCC) in South Africa and ensure timely response to regulatory authority quires and request information
• Ensure timely submission of ADRs to the respective regulatory authorities.
• Report processed ADRs to the local Regulatory Authority (MCC) as applicable, in accordance with local regulations and maintains a submission log

2. Regulatory Compliance
• Safety Data Exchange Agreements (SDEAs)- Identify, develop and execute SDEAs in all countries in the Region.
• Monitor new PVG developments in terms of regulations in the country and communicate the same to the RPP of Region Vb.

3. Regulatory Inspections
• Assist with the development and implementation of appropriate CAPA to ensure closure of inspection/audit observations.
• Assisting in ensuring regulatory compliance for activities relating to Pharmacovigilance in the region, e.g. notifying Corp of PSUR submissions to regulatory authorities and finalizing SDEAs.
• Assist with timely intimation of regulatory inspections and/or feedback to Corporate Pharmacovigilance

4. Training and Development
• Self-training on PVG SOPs and processes.
• PVG training of non-PVG employees of XXX staff.

5. SOP Management
• Assist with the development, review and implementation of PVG SOPs at Regional and country level.
• Assist with the development of local Pharmacovigilance SOPs for procedures that are specific to the country. Ensure compliance with the applicable Pharmacovigilance SOPs

6. Compliance Management
• Monthly reporting of PVG status by the 10th of every month to Corporate PVG office in India.

7. Adverse Drug Reaction Management
• Assist in establishing and maintaining a system in the Country for collection of information concerning adverse drug reactions (ADRs) with company products
• Follow up on local ADR cases for further clarification with the reporter and HCPs and completeness
• Forward ADR information collected to the Regional RPP.