Product Safety Associate

Based in the Raleigh, NC Corporate office - Hybrid (in office 3 days/wk) Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision.

Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products.

As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve.

We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team.

Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.

If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerz Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Product Associate is responsible for assisting upper management in establishing and maintaining all Product Safety functions, in accordance with FDA, Health Canada and European guidelines and regulations, governing pre- and post-marketing vigilance for all Merz Pharmaceuticals, LLC (Merz Therapeutics) products (drugs and biologics).

Responsible for addressing Product Safety project related administrative tasks.

A safety database SME responsible for all tasks related to the collection, processing, follow-up, and post-market regulatory reporting of all adverse events and pregnancy reports for Merz Therapeutics US, including applicable regulatory reporting for investigational products.Essential duties and responsibilitiesMajor dutiesDescription Adverse Event Case Processing and Oversight Ability to independently analyze and accurately process adverse event reports daily from all sources, for all types of products.

This includes an ability to provide an initial assessment of complex medical information and relevant lab results, and the ability to enter the report in the safety database, write comprehensive narrative summaries, and conduct follow-up for all types of products.

Literature review for AEs Responsible for the review of the scientific literature search results received from our literature vendor to identify potential reportable adverse event reports that will need to be processed and submitted to FDA.

Conducts periodic and timely reviews of literature reports to evaluate for AE and SAE cases to be entered as case reports.

On Time submission of AE Reports Ensures on time submission of individual AE and SAE case reports to worldwide regulatory agencies, partners, and affiliates in accordance with applicable regulations and agreed timelines.

Ensures that Merz Therapeutics US obligations with respect to Safety Data Exchange Agreements (SDEAs) are fulfilled in an appropriate and timely manner.

Safety database subject matter expert (SME), assists with internal and external request for...