Neeraj Raut

About Neeraj Raut

Highly Competent, diligent and consistent performer having 9+ years of experience in pharmacovigilance domain along with highest qualification of M. Pharmacy.

Experience

1. Lead Safety Science Specialist

   Fortrea

   Mar 2021 — Present · Pune, IN

   Coordinated the preparation and submission of periodic safety reports (PBRER and PADER) to regulatory authorities.• Contributed to the preparation of aggregate safety reports, including Periodic Benefit Risk Evaluation Report (PBRER) and Risk Evaluation and Mitigation Strategies (REMS) documents.• Leads aggregate report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PBRER, PADER, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).• Key contributor to safety profiling teams to ensure that case reports are accurately evaluated and databased, and authoring product specific guidelines for assigned products.• Leads the signal management process (i.e, signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.• Participated in inspections and audits by regulatory authorities, providing necessary documentation and expertise.• Function as a Point of Contact for the team for regulatory updates, quality assurance concepts, applicable procedures, practices and conventions.• Supported developing and maintaining pharmacovigilance procedures and Standard Operating Procedures (SOPs).• Lead or participate in training sessions for internal teams to ensure a deep understanding of pharmacovigilance practices, safety reporting, and regulatory requirements.• Generation of monthly reports including staff performance and project-specific metrics to ensure data accuracy and quality.

Education

• Sinhgad Technical Education Societys Smt. Kashibai Navale College of Pharmacy, Kondhawa bk.,Dist.Pune 48

  Master of Pharmacy

  2012 — 2014

• Sanjivani college of pharmaceutical education & research, kopargaon, Dist. Ahmednagar

  Bachelor's Degree

  2008 — 2012