Pharmazone is a leading Consulting company with a robust legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs,
Pharmacovigilance, GxP Compliance solutions to clients for improving patient’s lives through unique Commit-Collaborate-Carry Model.
Responsibility
- 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.
- Bond period is 2.5 years and Notice period is 3 months
- Submit with the original documents
Pay: Up to ₹50,000.00 per month
Work Location: In person
📌 Aggregate Report (India)
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📍 India
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