Role & responsibilities
- Preparation and review of different Aggregate reports like PSUR/PBRER, RMP, PADER, Annual safety reports and other safety reports
- Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.
- Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.
- Conduct routine and ad-hoc signal detection activities using statistical methods and data mining techniques.
- Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.
- Prepare query responses and provide to internal stakeholders and regulatory authorities as needed.




- Develop and refine methodologies for signal detection and risk assessment.
- Participate in audits and inspections related to signal detection processes.
- Stay updated on the latest developments in pharmacovigilance and signal detection methodologies
- Perform Ad-hoc activity reports as requested by health authorities.

Preferred candidate profile
- Previous 2-5 years' experience of drug safety medical writing, including PBRERs, DSURs
- Solid communication and presentation skill.
- Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry,veterinary medicine)

📌 Medical Writer Executive (Vadodara)
🏢 Novumgen
📍 Vadodara