I have extensive experience in writing clinical and regulatory documents in the Pharmaceutical industry which include regulatory and safety I have completed medical encoding (MeDRA), data and quality review management. My past experience included responsibilities for preparing safety sections within key documents such as Investigations Brochure, clinical study reports, writing safety narratives to be included in final study report and ensuring if risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labeling. I have participated in preparing and completing aggregate safety reports or documents for products such as PSUR, PBRER, and PADER for submission to regulatory agencies around the world. I have reviewed eCRF profiles, Rave, Safety Evaluations and Safety Trackers and hold expertise in ETQ (Cognos), CATSWEB (Webbi), SAE database, EDC, Argus, Arisg, MedDRA, WHO drug, ICD-9, Inform, CIOMs, E2B as well as other coding scheme.

Highlights:

• Management
• Oncology
• DS
• Query
• Medical
• Oracle
• Oracle Clinical
• Database
• Encoder
• Risk Management