Riddhima Engineer

Experience

• 

  Henkel Corporation

  Mar 2008 - Oct 2010

  R&D Principal Lab Technician

  -Formulated Transdermal products using various polymers, solvents and raw material.-Performed tests such as GC, IR, solids, viscosity on different types of solvents, raws and adhesives on various substrates.-QC and QA for drug delivery and Transdermal adhesives-Managed projects for Transdermal products-Prepared and analyzed laboratory reports and product release data.-Prepared and documented Transdermal adhesive samples for customers.-Analyzed customer complaints.

• 

  PharmaNet/i3

  Sept 2010 - Feb 2011

  Clinical Research Associate 1

  -Maintained study-specific tracking spreadsheets (e.g. patient enrollment, regulatory documents, site visits).-Performed In house duties as assigned by the project manager.-Prepared regulatory binders for study sites.-Prepared materials and binders for Investigator’s Meetings.-Obtained, reviewed and processed regulatory and administrative documents from investigator sites.-Resolved issues, questions and requests for additional study supplies.-Assisted in recruiting investigators for participation in clinical trials.-Prepared and process Serious Adverse Event (SAE) reports-Prepared project management reports-Reviewed CRFs and other clinical date for completeness and accuracy.-Resolved queries of CRF data with study site personnel.-Reviewed tables and listings generated from study data.-Assisted in review of draft study protocols-Assisted in developing CRFs-Assisted in writing SAE narratives for Clinical Study Reports. Show less

• 

  Covance

  Apr 2011 - Apr 2015

  • Provide leadership and management of projects ensuring that communications and processes are harmonized for assigned projects.• Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.• Process all adverse event reports reported either spontaneously from any source or from a clinical trial.• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines• Performing quality control (QC) of SAE reports for other members of the group.• Executing routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.• Participating in signal detection, trend and pattern recognition activities, as appropriate.• Preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.• Working with Data Management or client on reconciliation of safety databases, if appropriate.• Draft/modify and deliver safety presentations.• Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.• Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.• Preparing Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.• Prepare and participate in client or regulatory audits. Show less - Preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events.--Assisting in developing Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency. -Processing all serious adverse event reports and write narratives in client database.-Entering safety data and coding of adverse event data in various safety databases.-Communicating with the clients and the sites for query generation and resolution.-Preparing listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).Work with Data Management or client on reconciliation of safety databases.-Participating in signal detection and trend and pattern recognition activities.-Train less experienced safety staff in all aspects of case-handling, adverse event reporting. -Ensuring compliant safety reporting in accordance with US and international reporting regulations. -Participating in Covance project teams and client meetings.-Assisting in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.Therapeutic Experience• Cardiovascular Indications: Hypertension, Cardiovascular diseases: (Phase I/II/III)• Oncology: Prostate Cancer; Breast Cancer, Colorectal Cancer, Lung Cancer (Phase II/III)• Pulmonary Indication: Idiopathic Pulmonary Fibrosis : (Phase I/II)• Neurology/Psychiatric Indications: Alzheimer ; Fragile-X; Schizoprenia : (Phase II/III)• Musculo-Skeletal Indications: Arthritis : (Phase II/III) Show less

  • Senior Drug Safety Associate

    Nov 2013 - Apr 2015

  • Drug Safety Associate

    Apr 2011 - Oct 2013
• 

  Otsuka Pharmaceutical Companies (U.S.)

  May 2015 - now

  • Director, Global Head , Aggregate Reports & RMP Operations, GPV

    Aug 2024 - now

  • Associate Director

    Sept 2021 - Jul 2024

  • Senior Manager

    Aug 2019 - Oct 2021

  • Manager, Global Pharmacovigilance Operations

    May 2015 - Oct 2021