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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
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