Job DescriptionJob 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 responsesand 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 activityreports 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

📌 Hiring: Executive Medical Writer (Mandvi)
🏢 Novumgen
📍 Mandvi