QPPV and Senior Drug Safety Officer

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solution.

As our QPPV/Senior Drug Safety Officer youll be integral to our Project Delivery organization overseeing Drug Safety management. Your role entails adherence to company policies SOPs and regulatory standards.

Key Responsibilities:

• Lead QPPV responsibilities for key clients.
• Manage PostMarketing Safety projects efficiently.
• Write regulatory safety sections with expertise.
• Conduct thorough literature searches.
• Handle adverse event reports accurately and promptly.
• Ensure highquality case review and coding.
• Electronically report to regulatory authorities.
• Contribute to SOP development and improvement projects.
• Stay updated on industry regulations and guidelines.
• Mentor new personnel and participate in marketing activities

Position Requirements:

• Bachelors Degree in life science or nursing preferred or equivalent qualification.
• Extensive experience in the relevant field.
• Adaptability to fastpaced environments with shifting priorities.
• Proficiency in medical terminology and understanding of assigned drugs and therapeutic areas.
• Familiarity with Pharmacovigilance legislation.
• Ability to work independently or in team settings with minimal supervision.
• Strong written and verbal communication skills.
• Proficiency in a Nordic language is preferred.

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven 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 cores values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking 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.