Experience in safety submissions to regulatory authorities
Knowledge of emea, fda, and india pv guidelines
The role involves collaborating with sponsors on the design, preparation, and assembly of expedited and periodic safety report documents
Job Summary
The role involves collaborating with sponsors on the design, preparation, and assembly of expedited and periodic safety report documents.
Syneos Health is committed to building an inclusive culture where colleagues can authentically be themselves while driving patient progress.
Candidates must maintain compliance with Standard Operating Procedures, global drug regulations, and ensure all relevant documents are submitted to the Trial Master File.
Matching Summary
The role involves collaborating with sponsors on the design, preparation, and assembly of expedited and periodic safety report documents.
Skills & Requirements
Must-have
6 years Safety and Pharmacovigilance experience
Experience in safety submissions to regulatory authorities
Knowledge of EMEA, FDA, and India PV guidelines
Proficiency in Microsoft Office Suite and TeamShare
Understanding of ICH GCP and GVP regulations
Nice-to-have
Experience leading safety submission projects
Strong communication and presentation skills
Ability to work independently and in a team
Detail-oriented with high accuracy
Experience with TMF filing and oversight
Key Requirements
Bachelor's Degree in life science, nursing, or pharmacy
Minimum 6 years of Safety and Pharmacovigilance experience
Experience in Clinical Research Organization preferred
Thorough knowledge of medical terminology and safety database systems