Safety Submission Associate

Responsibilities

• Create and import submission content for PADERs utilizing enterprise content management platforms like Documentum
• Collaborate with Regulatory Affairs to ensure US FDA 356h forms are completed appropriately for scheduled PADER submissions
• Record approval and submission dates in global safety databases such as Oracle Argus
• Prepare final submission documentation and create cover letters for electronic signature approval
• Assist the Lead Safety Submission Specialist in the generation of US PADERs
• Assemble and bookmark PADERs according to specific regulatory requirements
• Generate all Author Support Documents associated with Global PSURs

Requirements

• High School diploma or equivalent
• Proficiency in speaking, comprehending, reading, and writing English
• Proficiency with Microsoft Office Suite
• Ability to read and interpret general business documents and write routine reports
• Ability to solve problems using prescribed procedures and analytical thinking

Preferred Qualifications

• 2 years of experience in the pharmaceutical industry
• Knowledge of US FDA regulatory agency requirements and guidances regarding postmarketing periodic reporting
• Advanced skills in publishing electronic submissions using Documentum and Oracle Argus
• Experience with Adobe Acrobat Professional

Benefits

• Competitive salaries
• Comprehensive benefits package
• Inclusive work environment

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. Our mission is to empower people worldwide to live healthier at every stage of life by providing access to high-quality medicines at scale, currently reaching approximately 1 billion patients annually.