Pharmacovigilance Officer

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Pharmacovigilance Officer to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree in Pharm
- B. Pharm/ BSc degree or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- Thorough knowledge of the current Medicines and Related Substances Act 101 of 1965, the current SA Pharmacy Act 53 of 1974, and current regulatory policies and guidelines of SAHPRA.
- 5 years of related experience in the vaccine/biotech / pharmaceutical industry or equivalent would be advantageous.
- At least 2-3 years of Pharmacovigilance experience in medicine registration in South Africa; corporate awareness
- Post-graduate training and/or ample work experience in Pharmacovigilance and risk management (regulatory agency or industry).
- Knowledge of SA & Sub-Sahara Africa laws and regulations / WHO guidance relevant to Pharmacovigilance.
- Experience in having faced successfully local and/ or international quality audits.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Setting up and maintaining pharmacovigilance systems within the organization (Support WHO prequalification, local and export legislation).
- Responsible for the overall coordination and evaluation standardization of the pharmacovigilance section
- Ensuring compliance with local and Sub-Saharan NRA requirements.
- Identify and implement group-wide Pharmacovigilance Policy and implement and maintain the appropriate SOPs within the business to ensure compliance.
- Carry out responsibilities in accordance with the organizations policies, industry standards, and applicable laws.
- Establish a Pharmacovigilance Risk Management plan for the introduction of new registrations into markets.
- Support Head of Department in establishing an annual pharmacovigilance budget.
- Ensure Pharmacovigilance services are delivered to all internal and/ or external stakeholders as defined and as per the departmental and/ or business calendar.
- Actively engage all non-performance issues regarding service delivery
- Respond/investigate adverse drug/vaccine events within the prescribed regulatory timeframes to the applicable NRAs in conjunction with Medical Advisor when Appropriate.
- Contractual oversight: Ensure appropriate pharmacovigilance agreements are in place with Contract Giver/ Contract Acceptors.
- Co-ordinate ADR investigations with consultant clinicians and Biovac personnel.
- Ensure a system for literature research is established and maintained.
- Identify/ Implement/ Ensure/ Provide ongoing site-wide pharmacovigilance training for employees and healthcare providers.
- Review and organization of PSURS/CCDs and ensure local labeling is in line with reference safety information.
- Continuous monitoring of all relevant worldwide safety alerts from Regulatory bodies to ensure that BIOVAC is aware of such information timeously.
- If required, prepare, and manage DHCP letters in line with required guidelines and organize timeous distribution to the relevant target audience.
- Build effective relationships with the Pharmacovigilance section of SAHPRA to ensure corporate objectives are met.
- Annual summary reports in preparation for submission to NADEM.
- Prepare for pharmacovigilance audits and have a plan of action in place before audits.
- Respond timeously to local and export NRA recommendations.
- Liaise with local and overseas principles.
- Review all existing Pharmacovigilance Agreements for compliance and requirements and update/ amend where necessary.
- Request and obtain Import & Export Permits.
- Liaise with local and overseas manufacturers.
- Screen/ proofread/ approve documentation for legal compliance, printed packaging specifications, and artwork for packaging material.
- Perform due diligence audits of pharmacovigilance service providers.
- Approve promotional material (advertising).

**Application Deadline: 15 August 2023**

**_Disclaimer: _**
- By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._