Safety & Pv Submission Specialist I (clinical Trial + Regulatory Intelligence) - Argentina Based
SyneosHealth
Argentina
Preparation of safety report documents
Tracking of safety submissions
Compliance with sops and global 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 developing its people through career progression, training, and fostering a Total Self culture where employees can authentically be themselves.
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 global regulations
Application of regulatory intelligence
Electronic document filing
Nice-to-have
Collaborative team environment
Supportive line management
Career development opportunities
Diversity and inclusion culture
Problem-solving mindset
Key Requirements
Knowledge of GCPs, ICH guidelines, and drug development process
Understanding of global drug/biologic/device regulations
Experience with safety reporting regulatory intelligence