Mukul Khandelwal

Experience

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  Bioclinica

  Jul 2019 - Sept 2021

  Drug Safety Associate

  *Ensured data integrity by conducting thorough reviews of entered information in safety database while working as a Quality Reviewer. Delivered valuable input to support team members. Tracked and maintained quality metrics *Worked as Case Processor: Responsible for data entry of Individual case safety reports (ICSR) into the safety database. Reviewed and evaluated AE case information to determine necessary actions in accordance with internal policies and procedures. Managed cases efficiently, consistently meeting deadlines and achieving high customer satisfaction scores. *Worked as a Medical Coder and Narrative Writer: Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD). Ensured the completeness and accuracy of data entered in various fields, while writing medically relevant safety narratives for cases. *Executed supplementary responsibilities: Consistently followed up with sites to address outstanding queries and adhered to department AE workflow protocols. Provided support and leadership to Dug Safety Associates in their daily tasks, proficient in all workflow tasks at a high level. Performed assigned drug safety related activities. Show less

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  Parexel

  Sept 2021 - Nov 2022

  Drug Safety Associate I

  Expertise in management of ICSRs of all case types (spontaneous and solicited programs) which includes Triage, Initiation, Duplication and complete data entry. *Expertise in MedDRA coding in accordance with MedDRA Term Selection. *Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. *Maintained good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, ICH guidelines on safety and efficacy, FDA guidelines, CIOMS and New EU PV legislation. *Expertise in processing literature cases. *Expertise in handling the ERP (Enterprise Resource Planning) system. Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with client policies. *Ensured timely communication with clients/customers Show less

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  Tata Consultancy Services

  Mar 2023 - now

  Business Process Lead/Pharmacovigilance Literature Review Expert

  Experience includes working as a literature reviewer.*Pre-selection and Review of literature as well as provision of project specific annotation in the Product Literature Information (PLI) Database.*Review of global literature, preselected by the SCP Global Research and Development Information (GRDI) for detection of single cases accordingly to SOP and Guidance Paper Documentation of review result in the Product Literature Information (PLI) database.*Requested full text of scripts, translated and reviewed them on request.*Handled literature articles from various stakeholders including License Partner, Global Safety Leader, Medical Affairs, Regulatory and project employees.*Creation of PLI entry for local and LCR cases. Perform indexing, perform entry of case details in PLI, and enter PLI number in Argus. Enhanced efficiency and accuracy by incorporating full text in Argus for LPCR cases.*Provides support to local sites for questions and issues arising from local literature review. Contributed to various aspects of single case creation by conducting literature reviews.*Final decision making on creation of global or local literature case reports.*Reviewed case deletion list for discrepancies in PLI and Argus.*Managed CAPA for global literature cases involving indexing and review. Show less