Job Title: Executive Medical Writer

nExperience: 2 to 4 Years

nLocation: Vadodara

n

nJob Responsibilities:

n

n

n
1. Preparation and review of different aggregate reports like PSUR/PBRER, RMP, PADER, Annual safety reports and other safety reports.
n
2. Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.
n
3. Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.
n
4. Conduct routine and ad-hoc signal detection activities using statistical methods and data mining techniques.
n
5. Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.
n
6. Prepare query responses and provide to internal stakeholders and regulatory authorities as needed.
n
7.



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

n

nQualifications:

n

n
- Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicine)
n
- Previous 2-3 years’ experience of drug safety medical writing, including PBRERs, DSURs, RMPs and other aggregate reports.
n

n

📌 Executive Medical Writer (Mandvi)
🏢 Novumgen
📍 Mandvi