Pharmacovigilance Associate G S S Pharma

1.0 - 2.0 years

3 - 4 Lacs

Bengaluru

Work from Office

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A key responsibility includes the preparation and maintenance of Risk Management Plans (RMPs), which involve identifying potential risks, outlining mitigation strategies, and ensuring regulatory compliance. Continuous monitoring of safety updates and detection of safety signals for client products is essential. All activities must be conducted in strict compliance with standard operating procedures (SOPs) and applicable regulatory requirements. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, and EVWEB Updates Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) Risk Management Plan (RMP) and Regulatory Documentation ICSR Processing and Reference Product Comparison

Posted 1 month ago

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Pharmacovigilance Senior Associate G S S Pharma

2.0 - 3.0 years

4 - 4 Lacs

Bengaluru

Work from Office

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), Regulatory Documentation, Reference Product Comparison, ICSR Process,

Posted 1 month ago

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