Laxmana Kini

About Laxmana Kini

Summary: Drug safety professional with more than 19+ years of experience (in Pharma R&D, KPO and BPS) in Project Management, Operations and Quality Assurance in Pharmacovigilance, Clinical Trial Management and Regulatory Affairs along with people management (recruitment, allocation, mentoring, performance management), leading team, Projects, Audits & Inspections.Previous experience included contributions in business development: RFIs/ RFPs, bid defense, resource estimation, pricing and due-diligence activities. As a project manager handled project budget, invoicing, FTE allocation and implemented consistent, efficient quality processes to meet timelines and deliverable according to client’s requirements and SOPs. Also handled a team of junior medical writers, senior medical writers, medical reviewers, project coordinators and team leads, including their goal setting, IDP and appraisals.Had a role in setting up a PV dept. in one of the pharma major, where role involved development of SOPs, WIs and quality processes and ensuring audit/inspection readiness. Specialties: Aggregate report writing as per EU, US, and ICH specifications, Risk Management Plan (RMP), Signal detection and Case processing in Argus and ARISg database, CAPA management, safety data exchange agreements, Team Handling, Project Management and Clinical trial management.

Experience

1. Senior Manager

   Tata Consultancy Services

   Nov 2023 — Present · Mumbai, IN

Education

• Manipal Academy of Higher Education

  M.Pharm, Pharmacy Practice

  2003 — 2005

• Manipal Academy of Higher Education

  B Pharm, Pharmacy

  1997 — 2002