Drug Safety Associate (home or office based)

Key Responsibilities

Support to handling of ICSRs in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with TFS/clients’ SOPs and regulatory requirements.

• Workflow and mailbox management
• Intake, triage and process cases and write narratives of AE and SAE reports, as required
• Code adverse events, medical history and concomitant medication
• Quality control
• Reconciliation
• Support medical information activities, if required
• Local and global literature review activities
• Correspondence and archiving
• Assist in registration and other activities relating to EudraVigilance (e.g. EV downloads, MLM)
• Participate in relevant project groups/meetings
• Assist in internal support to other relevant departments
• May provide updates of templates for safety handling in specific studies/projects according to relevant SOPs
• Actively contribute to the organization and development of routines to enhance the work at TFS

Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent

• Able to work in a fast-paced environment with changing priorities

• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas

• Have basic understanding of the Good Clinical Practice regulations, ICH guidelines and pharmacovigilance legislation and guidance (e.g. Good Pharmacovigilance Practices)

• Ability to work independently as well as in a team matrix organization with little or no supervision

• Proactive

• Excellent written and verbal communication skills

• Demonstrate proficiency using Microsoft office applications

Benefits

• Private Health Insurance
• Global General Liability Insurance

• Global Travel Insurance
• Internet costs are covered by TFS
• Flexible working schedule