Dr. Aruna Shravanthi Bakaraju

Angestellt, Senior Medical Reviewer, Celegence
Bangalore, Indien

Fähigkeiten und Kenntnisse

Pharmacovigilance
Individual case safety review
Risk Management plan (RMP)
Periodic safety Update report (PSUR)
Addendum to clinical overview (ACO)
Medical review
Labelling
Excipient review
QPPV support
Medical literature review
Microsoft Word
Microsoft Excel
PowerPoint
medical queries
Dossier review
GVP modules
Signal Managament
EVDAS
CCDS
Medical Justification document
MedDRA tool
ArisG
Argus
German B1
Klinische Forschung

Werdegang

Berufserfahrung von Aruna Shravanthi Bakaraju

  • Bis heute 4 Jahre und 8 Monate, seit Dez. 2020

    Senior Medical Reviewer

    Celegence

  • 2 Jahre und 1 Monat, Dez. 2018 - Dez. 2020

    Senior Medical safety Advisor

    IQVIA
  • 10 Monate, März 2018 - Dez. 2018

    Medical Executive Pharmacovigilance

    Bluefish Pharma GmbH

    Medical review of the individual case safety reports, Review and submission of RMP, PSUR, ACO. Labelling review, excipient label review, active participation in in-licensing of new products, dossier review, inputs on medical query, literature review, Signal management activities ( involved in signal Pilot project (EVDAS)), QPPV support activities, PSMF review, Audits and Inspections.

  • 3 Monate, Dez. 2017 - Feb. 2018

    Associate medical safety Advisor 1

    IQVIA - Quintiles and IMS Health are now IQVIA

    Review and verification of appropriate sections of adverse events, MedDRA coding, labeling, causality and provide a medical assessment comment, Review the source documents to assure medical accuracy; Medical assessment of literature articles. Medical evaluation of individual adverse event case safety reports, including but not limited to all serious, non-serious line listings, expedited reports and all pregnancy reports.

  • 10 Monate, Feb. 2017 - Nov. 2017

    Associate Manager Medical Surviellance

    IQVIA - Quintiles and IMS Health are now IQVIA

    Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labeling, causality and provide a medical assessment comment. Medical evaluation of individual adverse event case safety reports Review of non-serious line listings Literature syndication. Participate in signal detection efforts and related activities.

  • 1 Jahr und 2 Monate, Mai 2016 - Juni 2017

    Consultant Medical officer

    Apollo Life

    • Taking care of employee’s health. • Timely referral of the emergency cases. • Providing primary care to ill patients. • Providing medical advice for work related transfers, relieving etc

  • 1 Jahr und 11 Monate, Apr. 2015 - Feb. 2017

    Senior medical surveillance specialist

    IQVIA - Quintiles and IMS Health are now IQVIA

    Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labeling, causality and provide a medical assessment comment. Medical evaluation of non serious individual adverse event case safety reports Active follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness. Actively involved in case discussion with client and provide the valuable inputs to the team.

  • 1 Jahr, Apr. 2014 - März 2015

    Junior Resident in Cardiology

    Saveetha Medical College and Hospital

    Taking care of Cardiology OPD. Follow up of patients in wards Taking individual rounds in wards and followed by rounds with senior physician and reporting to the Senior Physician. Post-operative care of Coronary angiogram patients. Worked in various departments like Cardiology, ICU, and Casualty. Handling emergencies, both medical and surgical in the Casualty. Served as duty medical officer in Primary Health Centre. Appropriate and timely referrals after stabilization in the Primary Health Centre.

  • 1 Jahr, Apr. 2013 - März 2014

    Intern

    Saveetha medical college

Ausbildung von Aruna Shravanthi Bakaraju

  • 1 Jahr und 5 Monate, Nov. 2015 - März 2017

    Diabetology

    Medvarsity

    Diabetology

  • 4 Jahre und 7 Monate, Sep. 2008 - März 2013

    Human medicine

    Saveetha University

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

  • Hindi

    Fließend

  • Tamil

    Fließend

  • Telugu

    Muttersprache

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