Poshan Lal

About Poshan Lal

A highly motivated and ambitious individual with diverse working experience of 8+ years in fields of Project Management, Pharmacovigilance, Drug development, Safety & Regulatory reporting, Audit & Compliance management, Budget reviewing, is able to give timely and accurate advice, guidance, support and training to team members and individuals. Possessing excellent team leadership and management skills and having the ability to work with the minimum of supervision whilst leading a team of ten or more. Having a proven ability to lead by example, consistently hit targets, improve best practices and organize time efficiently.ACADEMIC CREDENTIALS• M.S.(Pharm), Pharmacoinformatics from National Institute of Pharmaceutical Education and Research (NIPER), Hajipur (Patna).• Bachelor of Pharmacy from Pt. Ravishankar Shukla University, Raipur.PROFESSIONAL SKILLS• Prepare and maintain process-related documents, including SMPs, SOPs, MOMs, training trackers, and error feedback trackers etc.• ICSR case processing activities include intake, triage, data entry, narrative writing, quality control.• Conduct in-line quality review of ICSR’s, monitor compliance and share with customers and management on monthly basis.• Identify late submissions, conduct root cause analysis (RCA), and provide corrective and preventive actions (CAPA).• Collaborate with cross functional teams, including pharmacovigilance solutions, PV Compliance & Quality, Medical Safety Review, Case Processing Vendor, to ensure alignment on safety related activities.• Contribute and work together with other operations leads for automation and innovation.• Led training and mentoring programs for new and existing team members.• Work on project start up, conduct, maintenance and close out activities for safety operations.• Act as SME in set up of safety database (Argus), internal tracking system (Apex) for compliance and quality monitoring and other safety systems.• Hands on review project budget, scope of work (SOW) and forecast estimate at completion (EAC) hours.• Participate in internal audits and inspections as needed and ensure timely resolution of any process findings related to ICSR quality.TECHNICAL SKILLS• Safety Databases: Argus 8.1• Clinical Databases: iMedidata Rave, Zelta (IBM CD), CTMS• Other Tools: Wingspan, Veeva Vaults, eTMF, Elvis• Compliance: Knowledge of GVP guidelines, Regulatory, ICH-GCP guidelines• Coding: MedDRA, WHO-DD• Literature review: PubMed• Office Applications: MS Office, MS Excel, PowerPoint• Programming: Basic knowledge of C, C++, Java, SQL

Experience

1. Team Lead

   IQVIA

   Apr 2022 — Present · Bengaluru, IN

Education

• National Institute of Pharmaceutical Education and Research, Hajipur

  Master of Science (M.S.), Pharmacoinformatics

  2014 — 2016

• University Institute of Pharmacy, Pt Ravishankar Shukla University Raipur

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2010 — 2014