Sanjeev Kumar

Experience

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  Ranbaxy

  Mar 2014 - Oct 2015

  Senior Officer Quality Control

  Analysis of finished products, Raw Materilals through HPLC, GC,

• 

  Wipro BPS

  Oct 2015 - Aug 2017

  Pharmacovigilance Associate

  •Review, Assess and Process Safety data on ARGUS Database according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.•Separation, storage and transfer of confidential data after evaluating the cases in the safety database ARGUS. •Performing coding of adverse events in line with MedDRA and WHO terms and initiation of follow-up activitiesProcessing and reviewing of E2B Cases•Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager. Show less

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  APCER Life Sciences

  Oct 2017 - Sept 2018

  Pharmacovigilance Associate

  •Triaging, Duplicate searching and Process Safety data on ARGUS Database according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.•Performing coding of adverse events in line with MedDRA and WHO terms and initiation of follow-up activities•Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager.

• 

  Elite Safety Sciences

  Sept 2018 - Aug 2021

  Pharmacovigilance Scientist

  Expertise in end to end processing of individual case safety reports (ICSRs) including triage, data entry and quality control (including clinical trails, spontaneous, literature and solicited programs) •Causality assessment •Performing coding of adverse events in line with MedDRA and WHO terms and initiation of follow-up activities •Mentoring and on job training for newly joined employee •Workflow and compliance management •Quality Review of safety data processed in ARGUS •Support in preparation of aggregate reports. Show less

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  Amneal Pharmaceuticals

  Sept 2021 - now

  Authoring of Risk Management Plans (RMPs) which includes educational materials, health care professional checklist, patient card etc and review of aggregate reports (PADER's), Signal (signal schedule preparation and frequency report generation, primary assessment), SOP's and WI's and Global literature search via Embase, Pubmed

  • Assistant Manager

    Mar 2024 - now

  • Senior Executive

    Sept 2021 - Mar 2024