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Lambda Therapeutics is hiring an Aggregate Report Writer (Pharmacovigilance) for its Ahmedabad office. This is an excellent opportunity for B.Pharm and M.Pharm professionals with 1–3 years of experience in aggregate safety report writing who are looking to build a strong career in pharmacovigilance regulatory writing.
If you have hands-on experience in PSUR, PADER, RMP, and global safety reporting, this role offers exposure to international regulatory standards and a collaborative work environment.
🔍 Job Details
- Job Title: Aggregate Report Writer – Pharmacovigilance
- Location: Ahmedabad, Gujarat (Work from Office)
- Experience Required: 1–3 years
- Qualification: B.Pharm / M.Pharm
- Company: Lambda Therapeutics
- Joining: Immediate joiners preferred
🧪 Key Responsibilities
- Prepare and review aggregate safety reports including PSUR, PADER, DSUR, RMP
- Ensure compliance with global pharmacovigilance regulations (ICH, EMA, US FDA)
- Perform medical review and safety data analysis for periodic reports
- Coordinate with cross-functional teams for timely submissions
- Maintain documentation as per SOPs and regulatory timelines
- Support audits and regulatory inspections when required
🎯 Required Skills & Qualifications
- Degree in Pharmacy (B.Pharm / M.Pharm)
- 1–3 years of experience in aggregate report writing
- Strong knowledge of pharmacovigilance processes
- Hands-on experience with PSUR, PADER, and RMP
- Excellent medical writing, analytical, and communication skills
- Ability to work independently and meet strict deadlines
💼 Salary & Benefits
- Salary Range: ₹4,00,000 – ₹7,00,000 per annum (CTC)
- Stable work-from-office role in Ahmedabad
- Exposure to global regulatory submissions
- Professional growth in pharmacovigilance & regulatory writing
- Supportive and structured work environment
📨 How to Apply
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