Pharmacovigilance Associate Entirety Hr Solutions

4.0 - 6.0 years

6 - 8 Lacs

bengaluru

Work from Office

Job Role: Senior Pharmacovigilance Associate 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 clien...

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