Saket Singh

Experience

• 

  Accenture, Banglore

  Oct 2006 - Dec 2010

  CDVA

  - Ensure the completeness and validity of the clinical trial data that has gone through data entry.- Working in EDC environment in InForm database. - Review and resolve discrepancies identified by the system or through manual checks as per guidelines.- Issue queries as and when required. Track, review and close all queries as per responses received.- Generate and review CRF Summary report and track missing CRFs.- Review and address all clinical data review issues.- Review and validate Bio-analytic data.- Provide expert comments and feedback on quality initiatives like DP Skills Center.- Interact with the on-shore resources regarding data quality issues.- Ensure timelines set by the client in terms of pages produced and clean patient delivery are met. - Mentor DVAs to perform editing until they are certified.- Assist team leaders in resolving complex issues- Quality Evaluation Focus.- Perform database quality reviews documenting findings for use in assessing the quality index.- Advanced skills in external data reconciliation. Show less

• 

  Accenture in India

  Jan 2010 - Mar 2015

  - Manage end to end Pharmacovigilance delivery for one of the top Pharma client.- Currently handles team of 170 FTE involved in Case processing & Literature search.- Apart from key roles as operation lead, hold other responsibility on account as Innovation and operation excellence lead, People advisor lead.- Ensure that the team meets defined service metrics (SLA) : Accuracy, Timelines and Productivity- Drive revenue generating six sigma projects and innovation tool for monetization.- Ensure key processes are managed effectively – recruitment, performance management, Metrics reporting, invoice, escalation etc. - Manage support processes (Invoice, MIS reports etc) efficiently- Drive & manage different processes required operationally viz. Recruiting process, Employee engagement, Employee idea process, Training etc.- Strategic Input - Liaison with senior management. Assist in the development of strategic plans for operational activity. Implement and manage operational plans.- Lead and work with the teams to optimize processes and use of Pharmacovigilance-related technology to build a more efficient organization. Encourage practical applications of new ideas. Show less - Managed Internal Operations for Accenture for team of 42 FTE- Manage stakeholders (Client, Accenture team, management) effectively - Ensuring that the team meets defined service metrics (SLA) : Accuracy, Timelines and Productivity- Ensure key processes are managed effectively - recruitment, performance management, Metrics reporting, invoice, escalation etc. - Manage support processes (Invoice, MIS reports etc.) efficiently- Provide feedback to improve performance of process / individuals where required- Effectively coach or counsel team on managing the process- Drive & manage different processes required operationally viz. Recruiting process, Employee engagement, Employee idea process, Training etc.- Develop and implement a continuous improvement program to increase efficiency & reduce costs. Show less

  • Senior Operation Manager (Pharmacovigilance)

    Sept 2013 - Mar 2015

  • Operation Manager CDM

    Jan 2010 - Sept 2013
• 

  Accenture

  Dec 2010 - Aug 2011

  Data Managment Lead

  Accountable for resource planning and for balancing workload within a team of Data Managers to ensure timelines are met.- Ensure that productivity targets for team, team members and self are met on a monthly basis.- Proactive identification of issues/ challenges and come up with solutions/mitigation plans.- Ensure that all client/ internal quality expectations are met.- Maintain communication and a good working relationship with the client.-Taking care of the training and maintaining documents. Provide feedback to improve performance of process / individuals where required Show less

• 

  Syneos Health Clinical Solutions

  May 2015 - Jul 2016

  Associate Director Pharmacovigilance

  Manage end to end Pharmacovigilance delivery center for one of the Top pharmaceutical client.- Direct the operations of the Global Safety and Pharmacovigilance in a region- Provide managerial oversight of the Global Safety and Pharmacovigilance Group- Ensure that InVentiv is in compliance with Safety reporting requirements of regulatory authorities- Currently handles team of 70 FTE involved in Case processing.- GSPV lead for EMEA, responsible for improving the delivery, setting up operational process, transforming client relation toward gaining more business.- Ensure that the team meets defined service metrics (SLA) : Accuracy, Timelines and Productivity- Ensure key processes are managed effectively – recruitment, performance management, Metrics reporting, invoice, escalation etc. - Strategic Input - Liaison with senior management. Assist in the development of strategic plans for operational activity. Implement and manage operational plans.- Coordinate with Medical affairs, clinical Research and Data Management for the efficient and timely review of safety information at inVentiv- Interact with clients and internal staff to provide advice and guidance on safety review issues: provide adequate input into client proposals- Lead the smooth transition of work ensuring the core delivery is not impacted and also enhance organic and inorganic growth. Show less

• 

  Accenture in India

  Jul 2016 - now

  Global PV Capability Lead- Operations Pharmacovigilance Capability lead and Global delivery lead Overseas the pharmacovigilance projects for India , China, Europe, Brazil & Japan. Responsible for delivery and business growth for PV capability

  • Principal Director

    Dec 2023 - now

  • Vice President pharmacovigilance

    Dec 2020 - Dec 2023

  • General Manager (Global delivery lead)

    Jul 2016 - Dec 2020