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.
Bond period is 2.5 years and Notice period is 3 months
Submit with the original documents