Safety & PV Submission Spec I
Core
Support the preparation, coordination, and submission of critical pharmacovigilance and drug safety reports to regulatory authorities, ethics committees, and clinical investigators.
Role type
Safety & PV Submission Specialist I
Builds
Safety reports and submission records for clinical trials and post-marketing safety programs
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Safety report preparation, Regulatory submission coordination, Documentation management, ICH guidelines knowledge, GCP/GVP compliance, Medical terminology, Data privacy adherence, Deadline management, Stakeholder collaboration, SOP/WI adherence
Preferred skills
Safety database systems experience, Clinical research background, Medical terminology expertise, Visio proficiency
Technologies
Microsoft Office (Word, Excel, PowerPoint), TeamShare, Outlook, Internet-based tools
Responsibilities
Assist with preparation and assembly of expedited and periodic safety reports, Support submission of safety reports to regulatory authorities, Maintain accurate tracking records for safety submissions, Review safety reporting documentation for completeness and compliance, Organize and file safety-related documentation, Distribute completed safety submission documents to clients
Seniority
Individual Contributor, Entry to Mid-level