Experience

• 

  Shree mahavir health and medical relief society

  Jun 2011 - Dec 2011

  Clinical research coordinator

  • Coordination of patient visits for ICF presentation and recruitment• Study start-up and Site initiation• Patient follow-up visits• CRF filling and cross checking• Ethics Committee submissions and communication• Maintain and update study logs and Site Master File• Safety reporting to sponsor and Ethics Committee• Archival of study documents after the study completion

• 

  Divyam hospital

  Jan 2012 - Mar 2014

  • Coordination with all concerned depts. for proper planning & execution of studies• Assist Monitor and Project Manager with feasibility analysis• Manage Pre-Site Selection Visits (PSSV) and Site Initiation Visit• Prepare documents (dossier) for Ethics Committee Submission• Execute the studies as per protocol, SOPs, GCP and other regulatory requirements• Verifying the documentation of the Informed Consent form for each study subject• IP handling, accountability & availability, tracking and management of all study supplies shipped to the sites• Reporting of the AEs and SAEs to the Ethics Committee, DCGI and Sponsor • Monitoring & performing IP dosing, food consumption, Blood and PK Sampling and its documentation, as applicable• Performing Check-in, Check-out & Ambulatory visits as per Study requirements• Assists to the auditor and QA personnel to ease audit and inspection• Preparation of all pre-study, during study & post-study documents related to study execution, making them ready for monitoring & audits• Preparation of Form 1572 & 3455 (for US-FDA submission study)• Third party Investigational Product retention (for US-FDA submission study)• Liaise with Pharmacy and Central Laboratory• Source Data Entry, e-CRF Completion and Query Resolution• Manage and update Investigator Site File/ Site Master File• Developing and updating SOPs for Site• Training of SOPs and other study related activities to the new joiners or Trainees Show less o Conduct Feasibilitieso Manage Pre Site Selection Visits (PSSV)o Schedule Patient Visitso Coordinate and liaise with Sponsor / CRO for Monitoring visits, Audits and Inspectionso Informed Consent (ICF)o Initial Assessment of Inclusion / Exclusion Criteriao Patient registration / randomizationo Liaise with Pharmacy and Central Laboratoryo Data Entry / CRF /e-CRF Completiono Communication with Ethics Committeeo Reporting AEs and SAEso Manage and update Investigator / Site File and Trial Master Fileo Send weekly Recruitment Status Log Show less

  • Senior Clinical Research Coordinator

    Jul 2013 - Mar 2014

  • Clinical Research Coordinator

    Jan 2012 - Jun 2013
• 

  Indian pharmacopoeia commission, pharmacovigilance programme of india, under mh & fw, govt of india

  Mar 2014 - May 2015

  Technical associate (pharmacovigilance)

  • Collection of ADR reports.• Handling of spontaneous cases received from the healthcare professionals.• Perform follow up with the complainant to check completeness as per SOPs.• Data entry into Vigiflow (WHO Drug Safety Database).• Reporting to PvPI National Coordinating Centre (PvPI NCC) through Vigiflow with the source data attached with each ADR case (ICSR).• Training/ sensitization/ feedback to physicians through newsletters circulated by the PvPI NCC.• Assessment of case reports for seriousness, causality and expectedness.• Adverse Drug Reactions and drug coding using WHO-ART and WHO-DD.• Manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries.• Writing case narratives.• Facilitating and preparing groundwork for Drug Safety Review meetings.• To interact directly with Clinical Pharmacologist, Physicians and Reporters to solve case related issues and queries. Show less

• 

  Lambda therapeutic research

  May 2015 - Aug 2022

  Senior executive- pharmacovigilance

  1. PV-Aggregate Reports (17-Jul-2017 to till date)• Quality Check of aggregate reports (including PSURs, PBRER, DSUR, PADERs, Addendum to Clinical overview, Safety assessment reports, etc)• Responding regulatory assessment reports on RMPs and PSURs (PSUSA, FAR, PAR)• Preparation of Risk Management Plan (For Generic products, Biosimilars and NCEs)• Compliance management (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements)• Prepare and update SOPs and Work Instructions as per current guidelines• Training and mentoring team members as per requirement.2. Pharmacovigilance system master file (PSMF), the Summary of Pharmacovigilance System Management (sPhVS) (From 25-May-2015 to 05-Aug-2017)• Support QPPV for Development and maintenance, including preparation and review of new and existing client PSMF & its annexure(s) and the Summary of Pharmacovigilance System.• Analyzing and updating the changes occurred on the Pharmacovigilance System and global safety database in PSMF and respective annexure(s).3. Pharmacovigilance System Administrator (Coordinating Validation and Change Control)PV System administrator (From 01-Jan-2016 to 05-Aug-2017)PV System administrator (Back-up) (From 25-May-2015 to 31-Dec-2015)• Single point of contact with safety database service provider• Responsible for co-ordination with vendor for new development in safety database• Responsible for change management process and co-ordination• Ensure the validation and testing deliverables are written in compliance with SOPs and other applicable guidelines• MedDRA upgradation• Development, validation and change management of the safety database and maintains oversight of the related processes• Performed Data Migration activities• Performed case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR. Show less

• 

  Emcure pharmaceuticals limited

  Aug 2022 - now

  Assistant manager

  Working as an Assistant Manager- Pharmacovigilance Quality Assurance (PVQA).