TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (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 work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Freelance Drug Safety Manager is responsible for managing Drug Safety/Vigilance activities and will work according to company policies, SOPs, and regulatory requirements.

Key Responsibilities:

1. 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.
2. Leadership & Project Management: Lead safety-only projects and cross-functional initiatives; oversee safety activities and ensure project execution aligns with standards.
3. Process & Quality Management: Develop and maintain SOPs, templates, and safety processes; implement new procedures and validate safety systems.
4. Regulatory Compliance: Stay updated on global pharmacovigilance regulations and ensure adherence across safety operations.
5. People Management: Line manage Drug Safety Unit staff, including coaching, mentoring, performance reviews, salary negotiations, and onboarding/training.
6. Administrative Duties: Approve time reports, manage travel expenses, and handle invoicing/revenue for 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.
• Scientific & Regulatory Knowledge: Strong understanding of medical terminology, therapeutic areas, GCP, ICH guidelines, pharmacovigilance legislation, and SOPs.
• Communication Skills: Excellent written and verbal communication skills, with the ability to convey complex safety information clearly.
• Technical Proficiency: Skilled in word processing; proficient with spreadsheets; presentation experience is a plus.
• Leadership & Mentorship: Proven ability to lead, mentor, and supervise Drug Safety personnel.
• Analytical Thinking: Demonstrates sound judgment and critical thinking in safety decision-making.

What We Offer

We offer a competitive salary, comprehensive benefits, and opportunities for growth in a collaborative environment. Join a team committed to making a difference in patients’ lives.

A Bit More About Us

Founded over 29 years ago in Lund, Sweden, TFS HealthScience is a full-service global CRO with over 800 professionals across more than 40 countries. We provide tailored clinical research services across therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and help us attract and retain talented professionals dedicated to excellence and innovation.

Together we make a difference.