Aggregate Report Specialist – Pharmacovigilance – Pharma Solutions

Aggregate Report Writer – Pharmacovigilance – Pharma Solutions

Experience: 3–6 Years (Preferred)
Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences
Preferred: Experience in Pharmacovigilance Aggregate Report Writing

Role Summary
Prepare and review aggregate safety reports, risk management plans, and signal management reports in compliance with global pharmacovigilance and regulatory requirements.

Key Responsibilities

• Author and review PSURs, PBRERs, PADERs, Annual Reports, DSURs, and ACO reports.
• Prepare and maintain Risk Management Plans (RMPs) and Signal Management Reports.
• Conduct literature searches, data validation, reconciliation, and benefit-risk assessments.
• Generate and validate Line Listings from safety databases.
• Ensure accurate documentation and compliance with regulatory guidelines and SOPs.
• Collaborate with Pharmacovigilance, Regulatory Affairs, Medical Writing, and Safety teams.
• Support regulatory submissions and meet strict project timelines.

Required Skills

• Strong knowledge of Pharmacovigilance and aggregate report writing.
• Knowledge of PSUR, PBRER, PADER, DSUR, RMP, and Signal Management.
• Understanding of global regulations including ICH, EMA, and FDA.
• Experience with safety databases such as Argus or ARISg is preferred.
• Strong scientific writing, analytical, data validation, and documentation skills.
• Excellent attention to detail and ability to manage multiple reports.