A leading life sciences recruitment firm is hiring an experienced Aggregate Report Writer to support pharmacovigilance and regulatory reporting activities. This opportunity is ideal for professionals with strong expertise in PSUR, PBRER, and DSUR writing, looking for a hybrid pharmacovigilance job in Noida with minimal office visits.
With increasing global regulatory scrutiny, aggregate safety reporting jobs are in high demand. This role offers exposure to international PV guidelines, cross-functional collaboration, and high-impact regulatory deliverables.
🧪 Key Responsibilities – Aggregate Safety Reporting
As an Aggregate Report Writer, you will be responsible for:
- Authoring and reviewing Aggregate Safety Reports including PSUR, PBRER, and DSUR
- Performing safety data analysis and signal trend evaluation across multiple sources
- Ensuring compliance with ICH, EMA, and global regulatory requirements
- Meeting strict regulatory submission timelines
- Responding to regulatory authority queries and incorporating feedback
- Collaborating with Pharmacovigilance, Medical, and Regulatory Affairs teams
- Maintaining high standards of quality, accuracy, and documentation
🎓 Eligibility Criteria & Qualifications
To qualify for this pharmacovigilance medical writing job, candidates must have:
- Minimum 5 years of experience in Aggregate Report Writing
- Proven expertise in PSUR / PBRER / DSUR
- Educational qualification: B.Pharm or M.Pharm
- Strong understanding of pharmacovigilance processes and safety guidelines
- Excellent medical writing, analytical, and documentation skills
💼 Work Model & Benefits
- Job Location: Noida, Uttar Pradesh
- Work Model: Hybrid (1–2 office visits per month)
- Competitive salary aligned with industry standards
- Exposure to global regulatory submissions
- Opportunity to work with experienced PV and regulatory professionals
📩 How to Apply
Interested and eligible candidates can apply for this Aggregate Report Writer job in Noida by sharing their updated resume at:
📧 Email: nirosha.k@2coms.com
Tip: Mention “Aggregate Report Writer – Noida” in the subject line for faster shortlisting.
