Drug Safety Associate - Freelance

TFS HealthScience; Mainz; Remote; EUR 60.000 - 80.000; Teilzeit

Zusammenfassung

A leading global Contract Research Organization is seeking a Freelance Drug Safety Associate in Mainz, Germany. This role involves managing drug safety activities, ensuring compliance with regulatory standards, and supporting the collection and documentation of safety data. Ideal candidates should have a Bachelor's degree in life sciences or nursing, knowledge of medical terminology, and the ability to work independently. The compensation package is competitive, with opportunities for professional growth.

Leistungen

Competitive compensation package

Comprehensive benefits

Opportunities for professional growth

Qualifikationen

• Understanding of drug development and therapeutic areas.
• Knowledge of pharmacovigilance legislation and operational SOPs.
• Ability to manage priorities with minimal supervision.

Aufgaben

• Handle and collect safety data in compliance with SOPs.
• Prepare and maintain safety documentation.
• Stay updated on GCP, ICH guidelines, and regulations.

Kenntnisse

Written and verbal communication

Understanding of medical terminology

Independent work in fast-paced environment

Knowledge of GCP and ICH guidelines

Ausbildung

Bachelor’s degree in life sciences, nursing, or equivalent

Jobbeschreibung

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

• Bachelor’s 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. 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 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.