Pharmaceuticals - Bengaluru, Karnataka, India
We provide specific solutions to monitor the safety of drugs and meet safety regulatory requirements for clients across the globe. Located in the garden city of Bangalore,Augur Safety Services is headed by leading experts in pharmacovigilance and risk based monitoring and audit. The internal standards developed are time tested and backed by strong operational knowledge. Our safety surveillance services are supported by strong scientific methods collaborated with validated medical analysis. Our team has work experience over a wide range of medicines including traditional medicines, blood products, biological products and medical devices and vaccines.Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.European union legislation for pharmacovigilance have been revised to meet the EU and dynamic market requirement.Marketing Authorisation Holders are now more responsible for preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure; promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.Now, the sponsor holds more responsibility of reporting, leading to the protection of patient and public health in EU region.Pharmacovigilance surveillance is connected by process that is based on good pharmacovigilance guidelines. The normal reporting and part of quality management and risk management system are more streamlined by the agency. Good vigilance practice provides guideline in each product and cycle management.