Safety Submission Associate

Viatris•Morgantown, WV

6d•$37,000 - $80,000•Onsite

About The Position

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. The Safety Submission Associate will make an impact by creating and importing submission content for PADERs utilizing an enterprise content management platform, collaborating with Regulatory Affairs to ensure US FDA 356h forms are completed appropriately, and recording approval and submission dates in the global safety database. This role also involves preparing final submission documentation, creating cover letters, assisting in the generation of US PADERs, assembling and bookmarking PADERs according to regulatory requirements, and generating Author Support Documents associated with Global PSURs. The company offers competitive salaries, benefits, and an inclusive environment.

Requirements

Minimum of HS diploma or equivalent.
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.
Proficiency in speaking, comprehending, reading and writing English is required.

Nice To Haves

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.

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.
Assists 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.
Perform other duties as assigned.