Safety Submission Associate

Key responsibilities

• Creates and imports submission content for PADERs utilizing an enterprise content management platform (i.e., Documentum).
• Collaborates with Regulatory Affairs to ensure US FDA 356h forms are completed appropriately for scheduled PADER submissions to the FDA.
• Records approval and submission dates in global safety database (i.e. Oracle Argus) upon receipt acknowledgment and prepares final submission documentation for case files.
• Creates cover letters in enterprise content management platform (i.e., Documentum) and obtains electronic signature approval for PADER submissions to FDA.
• Affords assistance to Lead Safety Submission Specialist in the generation of US PADERs.
• Assembles and bookmarks PADERs according to regulatory requirements.
• Generates all Author Support Documents associated with Global PSURs.
• Performs other duties as assigned.

Qualifications

• Minimum of HS diploma or equivalent and prefer 2 years of experience in pharmaceutical industry.
• Prefer knowledge of US FDA regulatory agency requirements and guidances under North America responsibilities in relation to postmarketing periodic reporting and electronic submissions.
• Prefer advanced skills in publishing electronic submissions utilizing systems such as Documentum, as well as Oracle Argus, Adobe Acrobat Professional and Microsoft Office Suite.
• Ability to read and interpret general business documents.
• Ability to write routine reports and general business correspondence.
• Ability to work with peers and communicate basic concepts.
• Ability to add, subtract, multiply, and divide.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
• Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.
• Proficiency in speaking, comprehending, reading and writing English is required.

Pay

$37,000.00 - $80,000.00 USD

Schedule

Not specified

Benefits

Not specified

Skills

Not specified

Benefits

Not specified