Tamaghna Bhattacharya
Angestellt, Pharmacovigilance Manager, Dr. Ebeling & Assoc. GmbH
Bis 2021, Public Health, Hochschule für Angewandte Wissenschaften Hamburg
Hamburg, Deutschland
Über mich
Results-driven medical doctor with nine years of experience in pharmacovigilance, specialising in Signal Detection, Safety Assessment reports, and quality control of individual case safety reports (ICSRs). Proficient in managing end-to-end processing of ICSRs, adverse event (AE) coding, seriousness determination, labelling, and writing company causality comments in compliance with regulatory timelines. Skilled in medical literature screening, signal management, and continuous benefit-risk assessment. Extensive expertise in therapeutic areas including oncology, cardiovascular care, primary care, women's healthcare, and consumer care. Excellent analytical and communication skills. Proficient in ARGUS, ARISg, Sapheus databases, and MedDRA.
Werdegang
Berufserfahrung von Tamaghna Bhattacharya
Bis heute 3 Jahre und 3 Monate, seit Feb. 2021
Pharmacovigilance Manager
Dr. Ebeling & Assoc. GmbH
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
1 Jahr, Aug. 2019 - Juli 2020
Pharmacovigilance Intern/ studentische Aushilfe
Abbott Laboratories GmbH
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
5 Jahre, Sep. 2013 - Aug. 2018
Pharmacovigilance Physician/Assistant Manager
Tata Consultancy Services, Mumbai, India
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
1 Jahr, März 2012 - Feb. 2013
Junior Resident, General Surgery
Deen Dayal Upadhyay Hospital New Delhi, India
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.
Ausbildung von Tamaghna Bhattacharya
2 Jahre und 7 Monate, Sep. 2018 - März 2021
Public Health
Hochschule für Angewandte Wissenschaften Hamburg
5 Jahre und 7 Monate, Sep. 2005 - März 2011
Human medicine
Luzhou Medical College, Luzhou City, China
Medicine, Surgery, Pharmacology, Gynecology-Obstetrics, Pathology, Community Medicine
Sprachen
Englisch
Muttersprache
Deutsch
Gut
Chinesisch
Grundlagen
Hindi
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Bengali
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