Drug Safety Officer (home or office based)

Job Purpose

The Drug Safety Officer is part of the Project Delivery organization and will work within the Safety Project Management & Aggregate Reports group according to company policies, SOPs and regulatory requirements.

Key Responsibilities

Support the management and oversight of clinical trial safety projects in TFS. Includes, acting as Functional Lead on clinical trials in accordance with TFS SOPs and regulatory requirements.

• Lead safety activities for clinical trial safety projects in TFS
• Involved in internal projects within safety and with other relevant departments
• Provide leadership and guidance to the assigned safety project team
• Oversee and monitor the performance of safety activities for assigned projects, including, but not limited to the preparation and oversight of key performance indicators
• Prepare and execute Safety Management Plans, Reconciliation Plans, and other clinical safety plans as required
• If, and as required, support the PV Operations team with SAE management activities such as processing, quality control and reporting
• SAE reconciliation
• Listings generation and quality control for periodic safety reports
• Support / lead the development of periodic safety reports (e.g. DSUR)
• Correspondence and archiving
• Represent Safety on full-service clinical trials and associated meetings
• 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 Safety 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 applications

Benefits

• Additional 5 days paid vacation per year, in accordance with the Company’s vacation policy

• Private Health Coverage
• Global General Liability Insurance
• Global Travel Insurance
• Lunch allowance for office based employees