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 1โ3 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.
๐ Job Location
Ahmedabad, Gujarat (Work from Office)
๐งช Job Responsibilities โ 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
๐ Required Qualifications & Skills
To be successful in this pharmacovigilance aggregate report writer job, candidates should have:
- 1โ3 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
๐ผ Why Apply?