We are Hiring: Drug Safety Associate
We are looking for a skilled professional to support our Pharmacovigilance operations. The role requires good knowledge of global PV guidelines, strong attention to detail and the ability to manage case processing and literature activities.
Key Responsibilities:
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.
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 (SOP’s) and regulations.
Location: Bangalore
Experience: 0 – 3 years in Pharmacovigilance (PV experience preferred)
Education: Pharm D / M.Pharm
If you are looking to build your career in Pharmacovigilance and be part of GSS Pharma’s expanding operation, we would love to hear from you.
Contact Details:
shilpa.a@gsspharma.com
aveen.r@gsspharma.com
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