Pharmacovigilance Specialist

The purpose of the role is to serve as Pharmacovigilance Specialist within the countries covered by the country operation i.e. South Africa and sub-Sahara Africa, and to ensure reporting of all adverse events in accordance with Global Pharmacovigilance procedures. The successful incumbent is responsible to ensure overall compliance with regards to Pharmacovigilance in the company as well as develop and maintain a Pharmacovigilance system in control for South Africa and responsible countries.

PRINCIPAL ACCOUNTABILITIES
- Responsible for adverse experience case management in his/her country(ies) of responsibility, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures, the review of local literature as per our Company's procedure and country regulations, and health authority submissions of cases in accordance with Global Pharmacovigilance procedures and health authority requirements.
- Associated responsibilities include the preparation of requests for updates/changes to country-level listings for the global safety database and the escalation of global safety database-related problems arising in country(ies).
- Responsible for aggregate safety report submission management in the country(ies), including report scheduling, submissions and submission compliance entries in accordance with Global Pharmacovigilance procedures and health authority requirements.
- Responsible for the reconciliation of adverse events reports received from other operating units and contractual partners, as applicable.
- Responsible for writing and maintaining the local country Pharmacovigilance Standard Operating Procedures, including alignment with our Companys policies and procedures and with Global Pharmacovigilance procedures.
- Responsible for being compliant with local Pharmacovigilance regulations, our Companys policies and procedures and Global Pharmacovigilance procedures at the country level.
- Accountable for monitoring of individual case safety report compliance and aggregate safety report compliance and responsible for the implementation of corrective actions locally, as necessary, for late reporting.
- Responsible for the monitoring of new/revised CA regulatory information related to Pharmacovigilance and for the timely implementation of the new/updated Pharmacovigilance regulations communicating changes to the Global Pharmacovigilance This includes liaising with Health Authorities regarding Pharmacovigilance regulations and reporting requirements in South Africa and Sub Sahara Africa.
- Responsible for preparing for audits/inspections for his/her country(ies) of responsibility and participate in the audit and/or inspection.
- Responsible for delivering company-wide training to all employees as well as distributors /vendors / business partners in the country(ies) within scope.
- Responsible for completing and documenting required Pharmacovigilance training within the required timelines.
- Responsible for attending all meetings involving the pharmacovigilance department and the recording and distribution of allocated meeting minutes within 48 hours to all relevant parties.
- Responsible for customer liaison and providing technical support in handling and resolving customer complaints within the Companion Animal Business Unit.
- To perform any other tasks required to ensure all aspects of the purpose statement are fulfilled.

KNOWLEDGE AND EXPERIENCE REQUIRED
Qualifications:

- Diploma in Veterinary Nursing or higher

**Experience**:

- Experience in clinical companion animal veterinary practice.
- Experience in dealing with customer complaints.
- High attention to detail.
- Good administration skills.
- Afrikaans and English (speak, read and write).
- Analytical and be able to work accurately under pressure.

Computer Literacy:

- The incumbent must be proficient in Microsoft Word, Powerpoint and Excel and able to learn pharmacovigilance database.

ACCOUNTABILITY MEASURES
- Technical Measures: Pharmacovigilance compliance for the entire range of products.
- People Measure: Foster teamwork and team environment
- Client satisfaction and client service, internal and external.

PERFORMANCE DIMENSIONS
- Planning and organizing
- Adaptability
- Initiative
- Teamwork
- Effective communication
- Proficient in local language(s)
- Good Documentation Practices
- Ability to learn new computer interface systems
- High level of accuracy & quality in work
- Strong collaboration skills
- Compliance mind set
- Tolerance for stress
- Energy
- Job motivation
- Enthusiasm
- High work standards

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals