Compliance /pharmacovigilance Scientist Internship

3 months ago


Cape Town, South Africa NRS Recruitment Full time

Leading Pharmaceutical comany is looking to employ a Compliance/ Pharmacovigilance Intern.

**Key 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

**PRE-REQUISITES**

**TECHNICAL COMPETENCIES REQUIRED**
- Excellent computer skills which includes working on electronic databases, as well as a good knowledge of software packages such as Word and Excel.
- Knowledge of the pharmaceutical industry is a strong advantage.

**Job Type**: Internship
Contract length: 12 months

**Salary**: R10 000,00 - R15 000,00 per month

**Education**:

- Bachelors (required)

Ability to Commute:

- Cape Town, Western Cape (required)



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