Assistant Vice President QA at Relicare Tech Services Pvt. Ltd. - Bengaluru, Karnataka, India
Senior Officer (Regulatory Affairs-Critical Care Division)
Relicare Tech Services is providing globally the Regulatory, Quality Assurance and Pharmacovigilance and Medical Affairs services. We specialise on end-to-end solutions for these specialised areas, employing qualified technical team with wide experience. The specialised area of services includes the following• Annual Product Reviews• Quality Management System (QMS) Documentation• Vendor Audit and Risk Management• Pharmacovigilance – ICSR, PSUR, DSUR, ASR CCSI etc.• Medical Information on customised software platforms.• Medical Writing, Promotional material review etc.• New Product Dossier in CTD formats from Module 1 to Module 5 including E –uploads for all regions of the world• DMF / CEP preparation including amendments, renewals & updates.• Life Cycle Management of dossiers• Pre-Registration and Post-Registration queries• Dossier Repatriation.