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.
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- Analyze safety data from various sources, including clinical trials, post-marketing reports, and literature.
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- Collaborate with cross-functional teams to assess and interpret data and generate signal detection reports.
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- Conduct routine and ad-hoc signal detection activities using statistical methods and data mining techniques.
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- Maintain knowledge of regulatory requirements and industry standards related to signal detection and pharmacovigilance.
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- Prepare query responsesand provide to internal stakeholders and regulatory authorities as needed.
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- Develop and refine methodologies for signal detection and risk assessment.
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- Participate in audits and inspections related to signal detection processes.
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- Stay updated on the latest developments in pharmacovigilance and signal detection methodologies.
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- Perform Ad-hoc activityreports as requested by health authorities.
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nQualifications:

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- Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicine)
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- Previous 2-3 years' experience of drug safety medical writing, including PBRERs, DSURs, RMPs and other aggregate reports.
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📌 Hiring: Executive Medical Writer (Mandvi)
🏢 Novumgen
📍 Mandvi