Drug Safety Officer (home or office based)

Job Purpose

The Drug Safety Associate is part of the Project Delivery organization and will work within the Pharmacovigilance Operations (PV Ops) group according to company policies, SOPs and regulatory requirements.

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.

• Intake, triage and process cases and write narratives of AE and SAE reports, as required
• Involved in internal projects within safety and with other relevant departments
• Code adverse events, medical history and concomitant medication
• Quality control
• Reconciliation
• Support medical information activities, if required
• Listings generation and quality control for periodic safety reports
• 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
• Support the development and update of departmental SOPs and procedures
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Being well-informed and updated on laws, directives and guidelines applicable to PV Operations activities
• May act as Project Manager for safety only projects
• Provide mentoring and supervision to other staff in the department and training both within and outside of the safety department.

Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• 3+ years relevant experience
• Able to work in a fast-paced environment with changing priorities
• Understand medical terminology and science associated with the assigned drugs and therapeutic areas
• Good 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 application

Benefits

• Entrusted work time

• Fitness Contribution
• Health Insurance
• Life insurance
• Global General Liability Insurance
• Global Travel Insurance