Drug Safety Associate Freelance

About this role

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 Freelance Drug Safety Associate handles drug safety and pharmacovigilance activities in accordance with TFS/client SOPs and regulatory requirements. The role provides flexible on-demand expertise to ensure accurate collection assessment coding and documentation of safety data.

Key Responsibilities:

• Manage the handling collection assessment and entry of SAEs AEs spontaneous reports related activities in compliance with SOPs and regulatory requirements; support narrative writing coding (AEs medical history concomitant medication) and SAE reconciliation.
• Prepare and maintain safety documentation including DCF handling correspondence and archiving ensuring accuracy and audit readiness.
• Contribute to study-specific safety processes including updating templates supporting internal departments and participating in project meetings.
• Stay updated on GCP ICH guidelines PV legislation and regulatory expectations relevant to clinical trials and market safety reporting.
• Support the continuous improvement of PV practices by identifying gaps proposing enhancements and contributing to routine development within TFS.
• Collaborate with project teams and stakeholders ensuring timely communication high-quality deliverables and alignment with agreed timelines and standards.

Qualifications:

• Bachelors degree in life sciences nursing or equivalent.
• Understanding of medical terminology drug development and relevant therapeutic areas.
• Knowledge of GCP ICH guidelines pharmacovigilance legislation and operational SOPs.
• Ability to work independently in a fast-paced environment managing priorities with minimal supervision.
• Strong written and verbal communication skills; proficiency with standard office tools.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 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.