Aggregate Report Specialist

Job Description: Aggregate Report Specialist

Location: Ahmedabad, Gujarat
Experience: 3–6 Years
Qualification: B.Pharm / M.Pharm / BDS
Employment Type: Full-Time
Salary: Up to ₹6 LPA

Job Overview

We are looking for an experienced Aggregate Report Specialist to manage pharmacovigilance reporting activities, ensuring the preparation, review, and submission of periodic safety reports and risk management documentation in compliance with applicable regulatory requirements.

Key Responsibilities

• Prepare, review, and manage PADER (Periodic Adverse Drug Experience Reports).
• Prepare and maintain PSUR (Periodic Safety Update Reports).
• Develop and update RMP (Risk Management Plans).
• Prepare, maintain, and update PSMF (Pharmacovigilance System Master File).
• Ensure compliance with applicable pharmacovigilance regulations and regulatory guidelines.
• Collect, analyze, and summarize safety data for aggregate reporting.
• Coordinate with cross-functional teams to ensure accurate and timely report preparation and submission.
• Maintain proper documentation and ensure data accuracy and quality.
• Support regulatory audits and inspections related to pharmacovigilance activities.

Required Skills & Qualifications

• Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm) or BDS.
• 3–6 years of relevant experience in pharmacovigilance and aggregate reporting.
• Hands-on experience with PADER, PSUR, RMP, and PSMF.
• Good understanding of pharmacovigilance regulations and drug safety reporting requirements.
• Strong analytical, documentation, and communication skills.
• Ability to manage multiple reporting activities and meet regulatory deadlines.

Salary & Location

• CTC: Up to ₹6 LPA
• Job Location: Ahmedabad, Gujarat
• Work Mode: Work From Office

Pay: ₹400,000.00 - ₹600,000.00 per year

Work Location: In person