CHANDRAKANTH SATHUR

Currently involved in activities relevant to EVDAS line listings, Manufacturing Lot review (DUPILUMAB), validity assessment of literature articles (case & non-case reports), writing cases summaries and MAH comments, Signal detection from articles on GLiMPs tool.

Authoring Safety Evaluation Reports, focused on literature section (WHO scale).

Generation and assessment of line listings (Medical concept reports) from PV database (ARGUS). Having good knowledge of American Medical Association Manual of Style guidelines.

Hands on experience in authoring “Monitored Event” reports, updating of List of safety topics (LST) and contribution of section 16 for PBRER.

Contribution of section “CHARACTERISATION OF RISKS” and “MISSING INFORMATION” for Addendum to Clinical Overview.

Experienced in data entry of ICSRs into the safety database (ARGUS), including assessing the expectedness of adverse events against various labelling documents (e.g., Summary of Product Characteristics (SmPC), Company Core Data Sheet (CCDS), Investigator Brochure (IB), writing case summaries, assessing causalities if necessary, and providing company comments when required.

Trained in Medical Dictionary for Regulatory Activities (MedDRA) coding in accordance with the guidelines of "MedDRA Term Selection: Points to Consider."

Experienced in processing literature cases, including those derived from medical journal abstracts, poster presentations, literature summary cases, and full literature articles (including interventional and non-interventional case studies and spontaneous reports).

Trained in reviewing and assessing the validity of articles, narrative writing as per chronology.

Maintain a good working knowledge of the adverse event (AE) safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client procedures, and international drug safety regulations.