Kundan Kumar

About Kundan Kumar

Dedicated pharmacovigilance professional with 11+ years of experience in…

Experience

1. Drug Safety Expert (Regional Safety Operations)

   Merck Group

   Nov 2021 — Present · Bengaluru, IN

   Collaborate with the PV agreement team to review SDEAs and implement ICSR exchange timeline changes in the LSMV distribution management system.Implementation of ICSR distribution rules in the LSMV system upon receiving new clinical trial approvals or submissions.To assist the LSMV database development team in User Acceptance Testing (UAT), ensuring regular updates are provided for the safety database.Authored and revised SOPs and Work Instructions supporting ICSR management in alignment with global PV regulations.Manage global/regional case workflow, ensuring prompt daily handling of all incoming ICSRs. Managing the Global Drug Safety mailbox, which involves tasks such as forwarding ICSRs to relevant stakeholders, addressing queries from partners and health authorities, resolving vendors case processing queries, and fulfilling other requests.Provide assistance to the local QPPVs (Qualified Persons for Pharmacovigilance) in USA, Middle East countries, Israel, Australia and New Zealand, ensuring smooth execution of pharmacovigilance processes at the country level.To assist local QPPVs with reconciling safety information and product complaints, ensuring accurate database documentation and timely forwarding for necessary actions, while also supporting audits, corrective action plans, investigations, and Health Authority inspections.Executed registration and transmission of global and local ICSRs into the safety database, conducted timely follow-ups on incomplete cases, and coordinated forwarding of Product Quality Complaints (PQCs) to QA/PV vendors for documentation in the PV database and Trackwise system.Conduct initial review of local literature for ICSR identification.Ensure timely communication of changes to local PV regulations and other relevant safety information to the PV team and ICSR vendors.

Education

• Central public School, samastipur

  6th Class to 10th

  2000 — 2006

• Balika vidyapith,Lakhisarai (Munger), Bihar

  12th

  2006 — 2008

• Roland Institute of Pharmaceutical Sciences (RIPS), Berhampur

  Bachelor in pharmacy

  2009 — 2013

Skills

• Clinical Trials
• Microsoft Office
• Regulatory Affairs
• Lifesciences
• Pharmacology
• Life Sciences
• Validation
• Global Rport Expedition of Icsrs
• Hplc
• Formulation
• Pharmaceutics
• Pharmacovigilance
• Gmp
• Glp
• Pharmaceutical Industry
• Sop
• Pharmaceutical Sales
• Clinical Research
• Global Reporting