Roles & Responsibilities:
• 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.
B Pharm/MPharm/ BDS
📌 Sr. Executive (Ahmedabad)
🏢 Actide International
📍 Ahmedabad
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