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Entirety Hr Solutions
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Pharmacovigilance Associate

Pharmacovigilance Associate

Entirety Hr Solutions

4 - 6 years

|

6 - 8 Lacs

Posted:2 months ago| Platform:

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Skills Required

pil spc analysis pharmacovigilance extended eudravigilance medicinal product dictionary patient information leaflet product characteristics drug safety case safety report aco

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job

Processing of the Individual Case Safety Reports (ICSR).
Literature screening activities.
Accountable for reviewing and assessing the validity of literature abstracts and articles with further processing onto the safety database if required.
Extended Eudravigilance Medical Product Dictionary (XEVMPD) maintenance and EVWEB updates including Summary of Product Characteristics (SPC/SmPC), Patient Information Leaflet (PIL) inserts and updates.
Preparation of Signal Detection Reports and Addendum to Clinical Overview (ACO).
Perform the review of SmPC and PIL in comparison to reference products.
Monitor the safety updates on safety signals for the client products.
Compliance to the standard operating procedures (SOPs) and regulations.

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