A leading pharmacovigilance organization is hiring an Aggregate Report Writer (Pharmacovigilance) for its Ahmedabad location. This is a work-from-office (WFO) opportunity for professionals with 1–3 years of experience in aggregate safety reporting. Immediate joiners and candidates from Gujarat are preferred.

If you have hands-on experience in PSUR, PADER, RMP, and global safety reporting, this role offers an excellent opportunity to strengthen your regulatory writing career in pharmacovigilance.

📍 Job Location

Ahmedabad, Gujarat (Work from Office)

🧪 Job Responsibilities – Aggregate Report Writer

As an Aggregate Report Writer in Pharmacovigilance, your key responsibilities will include:

• Preparation, authoring, and review of aggregate safety reports such as:
  • PSUR / PBRER
  • PADER
  • RMP
  • DSUR (if applicable)
• Ensuring compliance with global regulatory requirements (US FDA, EMA, ICH guidelines)
• Performing literature review and signal evaluation support
• Collaborating with pharmacovigilance, medical, and regulatory teams
• Supporting timely and high-quality submissions to global health authorities
• Maintaining documentation as per SOPs and regulatory standards

🎓 Required Qualifications & Skills

To be successful in this pharmacovigilance aggregate report writer job, candidates should have:

• 1–3 years of experience in aggregate safety reporting
• Educational background in:
  • B.Pharm / M.Pharm
  • PharmD
  • Life Sciences or related discipline
• Strong understanding of pharmacovigilance processes
• Excellent medical writing, analytical, and regulatory interpretation skills
• Ability to work independently, manage timelines, and meet deadlines
• Prior experience with global submissions is an added advantage

💼 Why Apply?

Application Link