Drug Safety Officer

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 Officer is an integral part of the Project Delivery organization, responsible for managing drug safety/vigilance issues in compliance with company policies, SOPs, and regulatory requirements.

This position is temporary and is available for a duration of one year with the potential for extension based on business needs.

Key Responsibilities:

• Manage Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market, ensuring meticulous collection, assessment, and entry into the safety database.
• Review and approve processed cases, conducting AE/SAE reconciliation.
• Code adverse events, medical history, and concomitant medication.
• Write safety sections in study protocols and clinical trial reports/IBs.
• Prepare safety documentation for regulatory submissions.
• Conduct literature searches and contribute to post-approval surveillance plans.
• Participate in safety-only project leadership and relevant meetings.
• Provide internal support, contribute to improvement projects, and enhance departmental routines.
• Validate computer applications and stay updated on pharmacovigilance regulations and guidelines.
• Educate and supervise new Drug Safety personnel, and support marketing activities.

Position Requirements:

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Relevant experience within the same field.
• Ability to work in a fast-paced environment with changing priorities.
• Understanding of medical terminology and science associated with assigned drugs and therapeutic areas.
• Understanding of Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation, and internal SOPs.
• Ability to work independently as well as in a team matrix organization with little or no supervision.
• Excellent written and verbal communication skills.
• Proficiency in typical word processing; spreadsheets desirable; presentation software a plus.

A Bit More About Us:

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light, serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.