Pharmazone is a leading Consulting company with a solid 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.
- The selected candidates will be required to sign a 2.5-year service agreement (bond period).
- As part of this process, candidates will be required to submit their original educational documents to the company's custody for the duration of the bond period.
- If a candidate requires the original documents during this period for any genuine purpose, they may submit a formal request to the HR team, and the documents will be provided accordingly.
- Upon successful completion of the 2.5-year bond period, all original documents will be returned to the employee.
- In the event that an employee is unable to continue with the organization due to a genuine reason before completing the bond period, they will be required to serve a 3-month notice period, after which they may separate from the organization as per company policy.
Pay: Up to ₹50,000.00 per month
Work Location: In person
📌 Aggregate Report (India)
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📍 India
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