/ http://www.slideshare.net/images/logo.gif / 際際滷Share feed for 際際滷shows by User: jayathin2 https://public.slidesharecdn.com/v2/images/profile-picture.png Highly ambitious professional with diverse pharmaceutical, device, and service industry experience in global drug safety/ Pharmacovigilance, Risk management. My capabilities and service offerings include the following: A) PHARMACOVIGILANCE: 1. Safety Surveillance and Risk Management (including preparation of RMP/REMS) 2. Signal Management & Safety data analyses 3. Global Labeling activities (for CCDS, SmPC, USPI, PIL, Dear Doctor letter etc.) 4. AE Case Management (ICSR processing) 5. Aggregate reports (PSUR/PBRER, AR, SBR, PADER, EU ASR, US IND-NDA) 6. Medical review & Quality Check (QC) of ICSR, all types of Safety & Regulatory documents, Publications, Medical literature or promotional...