Bhupendra Sharma

About Bhupendra Sharma

I am credited with 14+ years of experience in Pharmacovigilance and worked on Sceptre…

Experience

1. Senior Manager

   Cipla

   Sep 2022 — Present · Mumbai, IN

   Responsible for oversight of PV Operations (ICSR processing, Literature management (MLM, LRP) and Mailbox activities). • To review workload for team members and service providers. • To analyse performance of the team members periodically to ensure compliance with organizational SOPs • Monitor performance of Service provider as per SOW, KPI and SOPs • To identify areas of improvement in terms of compliance, quality, and productivity for team • To Monitor the Quality of activities performed by service providers • Attend weekly call, Monthly and quarterly call with Service provider and ensure timely escalation of outstanding issue • To ensure regulatory report are approved and submitted to partner or regulatory authority in appropriate format and within the appropriate timelines • To ensure on time escalation of IT related issue pertaining to Argus • To check and approve invoices of vendors • Role specific training to internal/external stake holders (if required) • Assistance during Internal Audits and Inspections • To participate in close out meetings of Internal Audits • Generation of monthly performance report • Handling of Deviation, CAPA, CR and other QMS related activities • To escalate instances of the repeated case processing error and non-compliance • Act as a case manager for Argus activities • Act as tier 1 admin for LMS • Co-ordinating and monitor trainings conducted by teams and ensure timely completion of attendance record.

Education

• Singhania University

  Master of Science - MS

  2022 — 2024

• Nexus

  Diploma

  2010 — 2010

• University of Mumbai

  Bachelor's degree

  2006 — 2010

Skills

• Management
• Pharmacovigilance
• CRO
• Medical Writing
• Clinical Research
• Clinical Trials
• Pharmaceutics
• Pharmaceutical Industry
• Fda
• Drug Safety
• Pharmaceuticals