TFS HealthScience is a leading global mid size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, strategic resourcing, and Functional Service Partnership solutions.
The Safety Physician provides independent medical and scientific expertise across pharmacovigilance and risk management activities, supporting the assessment and management of safety issues throughout the product lifecycle. The role ensures high quality medical evaluation in compliance with global regulatory requirements, company policies, and internal SOPs.
As part of our SRS/FSP team, you will be fully dedicated to one sponsor, AstraZeneca, a global pharmaceutical company and industry leader within its therapeutic areas.
• Perform medical assessment of suspected adverse reactions to medicinal products, including evaluation of seriousness, expectedness, causality, and clinical significance
• Provide medical review and input for aggregate safety deliverables such as PSUR, PSUSA, PBRER, DSUR, and Risk Management Plans
• Review and contribute to safety sections of clinical trial protocols, Investigator’s Brochures, and clinical study reports
• Deliver medical input to regulatory documents, responses to health authority questions, and benefit risk evaluations
• Conduct medical review and interpretation of safety literature and signal detection activities
• Provide expert medical advice on pharmacovigilance systems, safety risk management strategies, and internal processes
• Contribute to the development and maintenance of SOPs, guidance documents, and safety tools, and support training of drug safety personnel
• When required, support interactions with internal and external stakeholders, including participation in scientific or safety related presentations
• Medical Doctor degree
• Minimum five years of experience working as a Safety Physician or in a comparable pharmacovigilance medical role within the pharmaceutical or biotech industry
• Strong understanding of GCP, ICH guidelines, global pharmacovigilance legislation, and quality systems
• Ability to work independently within a complex, matrix based global organisation
• Proven capability to manage multiple priorities in a fast paced environment
• Excellent written and verbal communication skills in English
• Proficiency in standard office software, including word processing and presentation tools
We provide opportunities for personal and professional growth in a collaborative and rewarding environment. You will work closely with a leading global pharmaceutical sponsor while remaining part of the supportive and people focused TFS HealthScience organisation.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By living these values, we foster collaboration, innovation, and a strong shared commitment to making a difference for patients worldwide.
Our journey began over 30 years ago in Sweden, in the city of Lund. Today, TFS HealthScience is a full service global CRO with more than 600 professionals operating in over 50 countries. We build solution driven teams focused on delivering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes. With operations across 50 countries, TFS and its strategic partners provide tailored strategic resourcing solutions and clinical development services in specialized therapeutic areas, including dermatology, internal medicine, neuroscience, oncology, and ophthalmology. Dedicated to empowering partners and enriching lives, TFS offers flexible solutions that combine global reach with the agility and responsiveness of a mid-sized CRO.
For more information, visit www.tfscro.com.
