Aggregate Report Writer CLIN BIOSCIENCES
CLIN BIOSCIENCES
Office Location
Full Time
Experience: 0 - 0 years required
Pay: INR 500000 - INR 700000 /year
Type: Full Time
Location: Bangalore
Skills: argus safety, drug safety, Pharmacovigilance, pv openings in pune / mumbai / ahmedabad / noida / chennai, b.pharm / m.pharm / pharm.d, pv medical writing, pharmacovigilance in hyderabad, pv aggregate reporting, pharmacovigilance writer, drug safety report
About CLIN BIOSCIENCES
Job Description
Roles & Responsibilities
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Prepare and write aggregate safety reports
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Review and interpret safety data from ICSRs, clinical trials, literature, and signal detection systems
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Collaborate with safety physicians, regulatory teams, and PV specialists
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Ensure reports comply with ICH E2C, E2E, GVP, EMA, MOHAP, and FDA guidelines
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Maintain version control and audit-readiness of all aggregate reports
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Track timelines and ensure timely submission of reports to health authorities
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Integrate AI/NLP tools (if available) for literature review or data summarization
Qualifications
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B.Pharm / M.Pharm / Pharm.D OR M.Sc (Pharmacology / Clinical Research / Life Sciences)
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Strong knowledge of pharmacovigilance principles, clinical data, and regulatory reporting
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Familiarity with MedDRA, E2B(R3) standards, and global PV regulations
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Proficiency in medical writing, data interpretation, and use of templates/tools (e.g., Argus Safety, PV Works)
Interested to apply can share CV or call/whatsapp to 9342735755