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Drug Safety Associate

TFS HealthScience

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Location:
Germany, Mainz

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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:
  • competitive compensation package
  • comprehensive benefits
  • opportunity for personal and professional growth in a rewarding environment

Additional Information:

Job Posted:
December 12, 2025

Work Type:
Hybrid work
Job Link Share:

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