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Senior Executive – Pharmacovigilance

Senior Executive – Pharmacovigilance

Pharmazone

2 - 4 years

2 - 6 Lacs

ahmedabad

Posted:11 hours ago| Platform:

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Skills Required

medical writing arisg project management dsur pv itr drug safety scientific writing pharmacovigilance risk management plan ich rmp psur aggregate reporting pbrer case processing clinical research argus regulatory affairs meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities.
Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Reconciliation of relevant process trackers.
Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
Generation of Line Listings (LL) from safety database
Providing reliable support for high priority Ad-hoc activities.
Ensure all the reports are drafted within the allocated timelines.

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