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.