Aggregate Report

4 weeks ago

Ahmedabad, India Pharmazone Full time

Company Overview


Pharmazone is a leading Consulting company in the Pharmaceutical & Life Sciences industry, offering Regulatory Affairs, Pharmacovigilance, and GxP Compliance solutions. With a legacy of trust and a commitment to improving patient lives, Pharmazone has served 300+ clients globally.


Job Overview


A full-time role for a Junior Aggregate Report Specialist with 1 to 3 years of experience in Pharmacovigilance. The position is based in Ahmedabad, Gujarat, India.


Qualifications and Skills


  • 1-4 years of experience in Pharmacovigilance and Aggregate Reports
  • Knowledge of PSUR, PADER, and PABER requirements
  • Proficiency in Pharmacovigilance processes
  • Understanding of regulatory compliance in the pharmaceutical industry
  • Strong attention to detail and organizational skills


Roles and 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.


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