- Utilize deep knowledge of current regulations and internal processes/procedures to conduct quality audits to assess compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), GoodPharmacovigilance Practice (GVP), country-specific regulations and company policies/procedures- Provide timely, thorough, and unbiased audit reports- Provide consistent support to internal/external auditees, and stakeholders through various activities including CAPA implementation and regulatory authority inspections

- Adjudicate safety cases in ARISg/IRT/OST per ICH and FDA guidelines and drug safety reporting requirements- OST submissions to FDA/relevant Health Authorities- PV related Protocol Management and support for study teams- Safety Operations SME and Mentor / Trainer- Lead global projects, liaising with global stakeholders and outsourcing (TCS)