Tamaghna Bhattacharya

End-to-end processing and evaluation of ICSRs Screening of medical literature, signal management and continuous benefit risk assessment Planning and preparation of PSURs, Clinical Overviews (COs; Module 2.5) and Addendum to Clinical Overviews (AddCOs) Answering medical enquiries/requests regarding safety aspects of medicinal products Conducting trainings on MedDRA version updates

Established Medical Device Incident (MDI) data entry conventions, prepared system user manual following the European Medical Device Regulation, as well as the technical set up and system testing with the software vendor Prepared training materials and trained team members Supported the maintenance and updates of quality documents Updated MedDRA customized queries Prepared and updated Risk Management Plans of established pharmaceutical products

Reviewed literature articles Prepared PSURs and Addendum to Clinical overviews Coded AEs with the most suitable MedDRA terminologies and drugs with the WHO drug dictionary (WHO-DD) Ascertained the seriousness of AEs, labelling as per reference safety information, confirmed medical plausibility, determined causal association and wrote company causality comments Performed quality checks, root cause analysis, suggested quality improvement measures in case processing and trained new case evaluators

Treating patients at Emergency department and OPD; monitoring the treatment and condition of hospitalized surgical patients and assisting senior surgeons in surgeries and performing procedures.

Medicine, Surgery, Pharmacology, Gynecology-Obstetrics, Pathology, Community Medicine