Saurav Soni

About Saurav Soni

A Pharmacovigilance professional, with 11 years of experience in the industry. Leading the case initiation and ingestion process from multiple sources (Global/EMA/Affiliate/partner etc.) for a large global pharma company. Accountable for a team of around 75+ team members including a project training management team. Hands-on experience with all the industry databases used for ICSR processing. Expert in setting up case report handling and reconciliation processes. Serves as the SME during HA/Client/ internal / partner audits and inspection. Domain expert for coordinating with IT professionals in terms of process improvements on Artificial Intelligence based platforms with client’s IT vendors and inhouse as well. Also, an experienced trainer, a part of Company’s Induction training curriculum. Have Trained clients affiliates located at different sites. Involved in time calculation, resource management, monthly billing activity and annual budgeting for different processes of the project.

Experience

1. Senior Manager

   Parexel

   Apr 2019 — Present · Chandigarh, IN

   Liaises with Project Manager/Team Leads to understand the training needs of team members, as required• Provides training to team members on an ongoing basis, as and when processes/procedures are updated, or when new procedures are introduced• Ensuring to meet the requirements as in-Service Level Agreements• Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, preparing slide presentations, facilitating discussions & documenting conclusions• Active involvement with client’s IT partner company in process of development of artificial intelligence-based process improvement and development in case management process.• Effectively teamed up with IT team for the implementation of ERP (Enterprise resource planning). ERP configuration was done as per each team requirement with an aim to achieve easy accessibility of extensive data for different purposes as billing, estimates, metrics, check on overall health of the project via one system. Had numerous brainstorming session with the IT leads to meet the complex and different team specific requirements.• Pioneers from the company to handle E2B ingestion and processing when it was initially implemented via the health authorities • Involved with UAT testing at were initial stage of new clinical trial studies • Expert in streamlining the case ingestion process from all possible sources and therapeutic areas

Education

• MNDAV Dental College, Tatul, PO Oachghat, Distt. Solan

  Bachelor of Dental Surgery

  2003 — 2008