Shivam Singh

About Shivam Singh

I am a Pharmacovigilance (PV) professional with 14 plus years of experience and truly…

Experience

1. Assistant Manager

   Tata Consultancy Services

   Sep 2022 — Present

   Accountable for day-to-day case processing activities including Service Level Agreement monitoring with focus on quality and compliance. Manage, direct and guide a team of 20+ case processors. Workflow management (Forecast case volume and capacity planning on a daily basis). Responsible for quality, compliance and productivity delivery with confirmation of delivery through a metrics-based approach. Perform root cause analysis (RCA) and implement appropriate corrective and preventive measure (CAPA). Involved in resource estimation, hiring and succession planning. Set up the training plans for new hires according to the individual’s experience and job role and ensure training is provided as appropriate. Set up development plans for team members to further develop individual’s skills and potentials. Maintain a record of individual quality and compliance for direct report. Drive and maintain quality standards for client deliverables across the team. Ensure that the entire team follows best practices with regard to processes, communication, documentation and technical requirements. Conduct performance appraisals, grievance redressal and leave management for direct report.

Education

• Annamalai University

  B.Pharm

  2005 — 2009

Skills

• Clinical Trials
• Pharmacovigilance
• CRO
• Regulatory Affairs
• Lifesciences
• 21 Cfr Part 11
• Gcp
• Ich-Gcp
• Adverse Events
• Pharmaceutical Industry
• Medical Writing
• Meddra