Safety & Pv Submission Specialist I (clinical Trial + Regulatory Intelligence) - Argentina Based
Syneos Health
Argentina
Preparation of safety report documents
Tracking of safety submissions
Compliance with sops and regulations
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success
Job Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
The role involves assisting with preparation and assembly of expedited and periodic safety report documents and maintaining tracking of safety submissions.
The company is committed to career development, a supportive culture, and fostering diversity and inclusion globally.
Matching Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
Skills & Requirements
Must-have
Preparation of safety report documents
Tracking of safety submissions
Compliance with SOPs and regulations
Safety reporting regulatory intelligence
Filing and forwarding safety documents
Nice-to-have
Collaborative team environment
Career development and progression
Supportive and engaged line management
Diversity and inclusion culture
Key Requirements
Knowledge of global drug/biologic/device regulations
Understanding of GCPs and ICH guidelines
Experience with safety reporting and pharmacovigilance
Compliance with Standard Operating Procedures
Ability to interpret Global Safety & Pharmacovigilance Regulations