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| Job Location | Chennai |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Pharmacist / Medical Representative |
| EmploymentType | Full-time |
We are looking for Drug Safety Associate in Global Safety unit based out of Hyderabad/ Bangalore/Chennai, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.The position:In this role you will perform initial evaluation and case entry of all Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) in Argus. Also case entry and coding of adverse events from clinical trials phase I to IV based on individual Adverse events (AE) reports, correspondence with SO advisers, affiliates and other departments in Global Safety (GS) and various administrative assignments. Perform data verification between source data and Argus database and also ensure accurate and consistent medical coding of all events entered in Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities). Evaluate seriousness, causality and fistedness and write narratives to ensure regulatory compliance by following internal reporting key performance indicators.The position requires knowledge about the culture, practice and safety related procedures in the countries in which our company operates.Qualification:Required below skills and knowledge.Health care professional with extensive knowledge of medicinal terminology and clinical pharmacology as well as knowledge of patient treatment, diagnostic investigations and pathology.Solid knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safetyExtensive experience with IT, including MS Office (Word, Excel, Outlook, PowerPoint) and data entry.Have to write/speak English at a professional level.At Aquinova, your dedication, skills and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Keyskills :
safetydata entrypharmacovigilancecase processingcase