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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.
Join Our Team as a Freelance Drug Safety Manager - 0.25 FTE - (home based in UK, Poland, Portugal, Sweden or Spain.
About This Role
As part of our
CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The
Freelance Drug Safety Manager is responsible for for management in Drug Safety/Vigilance and will work according to company policies, SOPs and regulatory requirements.
Key Responsibilities
- Pharmacovigilance Oversight: Manage SAE handling in clinical trials and post-marketing, ensuring compliance with SOPs and regulatory requirements; review and approve safety cases, coding, and reconciliation.
- Leadership & Project Management: Lead safety-only projects and cross-functional initiatives; oversee departmental safety activities and ensure project execution aligns with legal and procedural standards.
- Process & Quality Management: Develop and maintain SOPs, templates, and safety processes; implement new procedures and validate safety-related systems.
- Regulatory Compliance: Stay updated on global pharmacovigilance regulations and ensure adherence across all safety operations.
- People Management: Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding/training of new personnel.
- Administrative Duties: Approve time reports, travel expenses, and manage invoicing/revenue for assigned projects.
Qualifications
- Extensive and proven Drug Safety Background.
- Adaptability & Independence: Thrive in fast-paced environments with shifting priorities; capable of working autonomously or within a matrix team structure.
- Scientific & Regulatory Knowledge: Strong grasp of medical terminology, therapeutic areas, GCP, ICH guidelines, pharmacovigilance legislation, and internal SOPs.
- Communication Skills: Excellent written and verbal communication, with the ability to clearly convey complex safety information.
- Technical Proficiency: Skilled in word processing; proficient with spreadsheets; presentation software experience is a plus.
- Leadership & Mentorship: Proven ability to lead, mentor, educate, and supervise Drug Safety personnel.
- Analytical Thinking: Demonstrates sound judgment and critical thinking in safety-related decision-making.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 29 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.
