Devaraju S

About Devaraju S

Safety surveillance activities for routine signal detection in ICSRs, clinical trials & literatures. Management of labeling changes for clinical overview reports. Medical review of clinical trial data, case analysis of documents and submission to regulatory authorities. Drafted PSURs (PBRERs), PADERS, Benefit risk report for mature products, Signal detection, PRAC assessments, Responding to HA queries, inputs for few sections of RMP and Literature analysis. QC of the reports for medical contents and accuracy. Drafted templates for PBRER and DSUR in regulatory format.Subject Matter Expert role & team training/mentoring responsibilities in aggregate reports and safety surveillance activities. Managing a Team and allocating resources effectively. Delivering high performance by creating positive environment and supporting team members. Measuring team member’s performance and providing appropriate feedback in timely manner. Meeting client managers to discuss the operations of the team, planning of the work & delivery of the reports.

Experience

1. Senior Director

   Eli Lilly and Company

   Oct 2023 — Present

   Provide global medical leadership and input into all aspects of safety of product(s) including surveillance programs and risk management planning in Early phase.Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities, represent PV position to Global Patient Labeling Committee and/or the Safety Review Committee as appropriate.Provide input to Global Patient Safety Leadership Team and Safety Review Committee

Education

• JSS medical college , Mysore, Karnataka, India

  Dch, Paediatrics

  2003 — 2005

• JSS medical college, Mysore, Karnataka, India

  MBBS, Medicine

  1995 — 2001