Job Description
Job Title: Aggregate Report Writer (Medical Report Writer)
nLocation: Vadodara
nExperience: 1 to 3 Years
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nKey Responsibility:
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- Preparation and review of different aggregate reports like PSUR/PBRER, RMP, PADER, Annual safety reports and other safety reportsn
- 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 methodologiesn
- Perform Ad-hoc activity reports as requested by health authorities.n

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nQualifications:
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- Bachelors or Masters in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicines.n
- Previous 1-3 years’ experience of drug safety medical writing, including PBRERs, DSURs, RMPs and other aggregate reportsn
- Time management, organisation and multitasking skills with good attention to detailn
- Solid communication and presentation skillsn
- Advanced knowledge of MS Officen
- Fluency in Englishn

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📌 Aggregate Report Writer (Mandvi)
🏢 Novumgen
📍 Mandvi