Aggregate Report Writer @ Clin Biosciences

Job Description

Roles & Responsibilities

• Prepare and write aggregate safety reports

• Review and interpret safety data from ICSRs, clinical trials, literature, and signal detection systems

• Collaborate with safety physicians, regulatory teams, and PV specialists

• Ensure reports comply with ICH E2C, E2E, GVP, EMA, MOHAP, and FDA guidelines

• Maintain version control and audit-readiness of all aggregate reports

• Track timelines and ensure timely submission of reports to health authorities

• Integrate AI/NLP tools (if available) for literature review or data summarization

Qualifications

• B.Pharm / M.Pharm / Pharm.D OR M.Sc (Pharmacology / Clinical Research / Life Sciences)

• Strong knowledge of pharmacovigilance principles, clinical data, and regulatory reporting

• Familiarity with MedDRA, E2B(R3) standards, and global PV regulations

• Proficiency in medical writing, data interpretation, and use of templates/tools (e.g., Argus Safety, PV Works)

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Keyskills:   argus safety drug safety pharmacovigilance