Compliance and Pharmacovigilance Intern
3 months ago
**KEY RESPONSIBILITIES**
**Compliance and Pharmacovigilance responsibilities**
- Ensure compliance of current dossiers in line with SAHPRA approvals, product history and pending approvals as well as in neighboring countries e.g. CEP, validation and stability information
- To ensure the integrity of data of any current or potential Regulatory/Quality databases and processes e.g. validity of certificates
- Ensure the accuracy of the CCP database information and timeous closing of CCPs
- Manage the implementation, recording and control of a Master List of products accurately
- Monitor non-conformance of variations in dossiers and Professional information/ Patient information leaflets in Export countries
- Check all Professional information/Patient information leaflets content according to a checklist provided
- Tracking of Professional information/Patient information leaflets Safety updates and availability and market implementation
- Track timeous updates of Pharmacovigilance Professional information/Patient information leaflets and market implementation
- Track updated Professional information/Patient information leaflets availability on the website
- Assist with the update of all Product appendices of Pharmacovigilance Agreements and queries
- Assist with the preparation of audit readiness
- Assist with obtaining risk reports in liaison with Lupin and Export division
- Ensure timeous upload of all training material on Policy Passport and printing of monthly status reports
- Assist with identifying any potential gaps and/or non-adherence to SAHPRA requirements and Quality Management System
- Assist with tracking of any outstanding actions relating to risk reports and/or identified gaps
**Documentation & Systems Management**
- Assist with the compilation and tracking of Compliance, Pharmacovigilance, Regulatory and Quality activities
- Assist in adherence to SOP’s and departmental deadlines
- Assist with Launch checklists
**General**
- Perform any other duties as per changes in operational requirements of the departments.
- Perform any other duties as requested
**PRE-REQUISITES
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