Pharmacovigilance

Job Description

1. To provide pharmacovigilance advice and safety reporting services to support regulatory compliance
2. To assist in ensuring that safety reporting complies regulatory guidelines and to input into protocol development specifically around drug and device safety reporting.
3. To support the optimization of the pharmacovigilance process and to input into documentation for safety reporting.
4. To provide training to various groups on pharmacovigilance
5. Review of protocols for pharmacovigilance, guidance and advice on required and desirable pharmacovigilance activities.
6. Support the setup and implementation of pharmacovigilance activities, including staff training, drafting and reviewing SOPs, ongoing review of SOPs, facilitating drug supply
7. Ensure timely notification of safety-related issues, in line with institutional and relevant legislative statutes and regulations
8. Data entry into data capture software and databases
9. Support the ongoing monitoring of study conduct to ensure compliance with study safety SOPs via site visits and study metrics
10. Assisting in the reconciliation of study databases
11. Assisting with analysing data and the preparation of clinical study reports, publications, final reports and presentations
12. Support the development of tools to help enhance understanding of pharmacovigilance at all levels across the organisation
13. Supervision of the receipt, processing and forwarding of case reports from on-going projects, ongoing management of the pharmacovigilance system
14. Continuous review of aggregated safety data as per SOPs, to ensure potential safety issues are identified in a timely manner
15. Periodic review of the database for potential safety issues

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