Job Description
Job Title: Executive Medical Writer
nExperience: 2 to 4 Years
nLocation: Vadodara
nJob Responsibilities:
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- Preparation and review of different aggregate reports like PSUR/PBRER, RMP, PADER, Annual safety reports and other safety reports.n
- Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.n
- Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.n
- Conduct routine and ad-hoc signal detection activities using statistical methods and data mining techniques.n
- Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.n
- Prepare query responses and provide to internal stakeholders and regulatory authorities as needed.n




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

nQualifications:
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- 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

📌 Executive Medical Writer (Mandvi)
🏢 Novumgen
📍 Mandvi