Surisha Duijndam-Padayatchi

Post marketing product with an active clinical development program in myelofibrosis Responses to Health Authority requests often with short deadlines Writing medical safety assessment (at times with collaboration of the cross functional team). Presenting safety data/training members of the benefit-risk team Collaboration with external vendors, and writing aggregate reports Update and preparation of safety section(s) for different labels (USPI and core company data sheet).

Responsible for all signal detection activities and aggregate reports.

Safety scientist (phase 2 and 3) and pediatric clinical trials - neuroscience Responsible for collating and presenting the safety updates at iDMC and cross-functional meetings Updating DSUR's, IB's, protocols and writing safety assessments Signal detection activities Reviewing of clinical data and laboratory values for safety purposes Working with vendors for ICSR narrative writing ensuring timely submission Working in a complex matrix organization across different time-zones

Authoring PBRER's and RMP's for several different cardio-vascular and oncology products. Ensure compliance and submission of aggregate reports Responding to health authority requests by in-depth analysis Process improvement projects from initiation to global SOP updates Training/mentoring junior staff members Signal detection activities Setting up processes for outsourcing aggregate reports to vendors. Guiding and training vendors. Monitoring quality and KPI management. Adverse drug reaction justification document