Drug Safety Associate

Job description

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The Drug Safety Associate is responsible for is part of the Project Delivery organization and will work with assistance on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements. Key Responsibilities: Support to handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing demands of the authorities. May review cases and write draft narratives of AE and SAE reports, as required. May code adverse events, medical history and concomitant medication. Support to SAE-reconciliation. DCF handling. Correspondence and archiving. Assist in registration and other matters of EudraVigilance. Participate in relevant project groups/meetings. Assist in internal support to other relevant departments....