Experience

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  Dr. ram manohar lohia hospital(pgimer)

  Mar 2016 - Apr 2016

  Trainee

  Clinical Trial Planning & Design,Biostatistics,Ethics in Clinical Trials.

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  Sun pharma

  Oct 2016 - Nov 2016

  Trainee

  Protocol Designing, Subject Recruitment & Screening, Clinical Study, Project Management, Method Development and Validation, Bioanalysis, PK & Statistical analysis & Report Writing.

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  Win-medicare pvt. ltd.

  Jan 2017 - Apr 2017

  Pharmacovigilance intern

  DissertationData entry of case reports into safety database / tracking systemPerformed literature searchesElectronic documentation and quality control of drug safety informationCoding of data in the safety database

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  Iqvia

  Nov 2017 - Mar 2023

  •Responsible for review of literature of potential Individual case safety reports (ICSRs), aggregate reports and signal detection following company standard operating procedures, safety management plan (SMP) and regulatory guidance documents.• Responsible for performing global and local literature review for projects assigned.• Involved in the global literature review through screening of safety information from widely used biomedical literature databases such as EMBASE and MEDLINE.• Responsible for forwarding potential ICSRs to case management centers.• Participation in all internal and project team meetings. Show less 1. Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review.2. Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local IQVIA offices to facilitate expedited reporting.3. Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.4. Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.5. Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.6. Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.7. Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. Show less

  • Safety Aggregate Report Specialist

    Jun 2021 - Mar 2023

  • Operations Specialist

    Nov 2019 - Jun 2021

  • Drug Safety Associate

    Nov 2017 - Oct 2019