Pankaj Walsetwar

About Pankaj Walsetwar

ArisG database-Triage and classify ICSRs for report type, seriousness, causality, labeling and reporting, priontize ICSR according to regulatory requirements -Completion of remaining case data entry, including narrative or auto-narrative -Completion of risk and quality (label, approval, and manual coding)-Clarification of unclear or illegible information from the ICSR sender (i.e. local safety officer [LSO) or Call Centre).Liaise with appropriate stakeholders (e.g. Global Medical Safety Operations Physicians [GMSOP], LabCorp Pharmacovigilance Physicians (PVPs)) to clarify appropriate information required for case processing-Prioritization of incoming cases for daily workflow management-Participation in assigned projects, including inspection/audit readiness activities and inspection and audits as identified, including interviews and provision of requested data-Other activities relating to case processing as appropriate per case, including but not limited to-Single case unblinding, Serious Adverse Event (SAE) reconciliation, deviation Meno preparation-deletion/requests as needed-Mentoring/training new hires, if required-Responding to J&J in a timely manner-Involve and support quality improvement trainings and initiatives-Quality Review: Perform Quality Review of ICSRs after the data entry. Participate in project teams to improve ICSR quality. Document the quality review results and provide feedback to relevant team members. Identify trends in errors and help identify training needs.

Experience

1. Safety Science Analyst

   Fortrea

   Apr 2023 — Present · Pune, IN

Education

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm

  2018 — 2022