Assistant Pharmacovigilance Manager

6 - 10 years

7 - 10 Lacs

mumbai navi mumbai mumbai (all areas)

Posted:None| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description:

• Maintain Argus safety data base console, routine maintenance and work closely with Oracle and other Vendor during system upgrade

• Review of Validation deliverables prepared by Vendor

• Perform XML ICSR Data migration as part of Company Integration and/or Acquisition and merger. Support Database Vendor for Database to Database dump method for ICSR migration

• Ensure Change controls are raised and closed in timely manner

• Management of user licenses and delegation of role privileges with support from Oracle

• Upgrade of dictionary, product list and Reporting Rules in Argus

• Generation of all the type of Listings from Front of Argus

• Revise and/or supervise revision and approve the scientific documents for the products marketed by the Company, such as summary product characteristics (SPC), patient information leaflet/literature (PIL) etc.

• Involvement in pre and post action arising from PV audits and inspections

• Draft responses to medical Queries and support Medical information team to provide data from

Safety Database.

• Support team in reviewing cases and managing Quality Measuring Tool with the outsourced PV

vendor

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Cipla logo
Cipla

Pharmaceuticals

Mumbai

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