You will drive reports of drug side-effects from post-marketed or clinical study source to the safety database. Handle non-serious and serious cases according to regulatory requirements, process instructions and standard operational procedures. Resolve queries related to pharmacovigilance activities and individual case reports.
Processing of adverse event reports
- Enter complete information from the safety report
- Perform appropriate clinical assessment (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements.
- Code reported adverse events with Meddra
- Seek medical advice
- Raise queries if needed
- Proper triage of the case
- Archive the source document
- Complete data entry according to the process instructions
- Perform all activities within the required timeframes
- Bachelor’s Degree in Life Sciences or Healthcare degree.
- Advanced competency with medical and therapeutic terminology
- Prior Experience in pharmacovigilance
- A minimum of 2 years’ experience in Pharmaceutical industry or in a clinical setting (including experience in hospitals, nursing homes, or clinics) is preferred;
- Experience in researching information utilizing available resources including publications and the World Wide Web;