Savej Ali

Safety & Pv Specialist 1 @Syneos Health

Gurugram, IN

Perform Data Entry of ICSR from various sources like Spontaneous, MHRA, Eudravigilance, Post Marketing studyand Literature cases.• Assist the WFM (Workflow manager) and Sr Manager in overseeing/conducting process activities like, followup attempt, Action item addressing and ICSR acceptance from Mosaic to ensure compliance with client’s SOPs.• Competent in Data Entry of Drug & Device, Drug, and Device only.• Support the processing of ICSRs in alignment with Standard Operating Procedures (SOPs) and project-specificsafety plans, including book-in, triaging, evaluating data accuracy, and ensuring regulatory compliance• Uphold compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), globaldrug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules,study/program plans and the drug development process.• Proficiently entered and managed information within PVG quality and tracking systems to facilitate the receiptand tracking of Individual Case Safety Reports (ICSRs) by ensuring accuracy and completeness.• Responsible for managing Follow up activities for the more than 25 products with different therapeutic areasincluding osteoporosis, migraine and cluster headache, diabetes mellitus and cancer.• Manages the translation process for any source documents requiring translation.