Product Safety Associate

Based in the Raleigh, NC Corporate office - Hybrid 

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, biologics and drug/device). 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 responsibilities

Major duties

Description

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 safety data

An expert user of the safety database is responsible for working with Global Product Safety, IT and the safety database vendor to problem solve and suggest database improvements as needed/required. Also responsible for generating database outputs, including those to be used for submissions and signal detection.

Interpretation of individual AE reports and safety data

Works closely with the Product Safety Officers to obtain medical review and assessment on individual AE case reports.  Maintains general knowledge of signals, trends, and closely monitored events. Communicates any potential safety issue appropriately. Able to make a preliminary clinical judgment regarding whether or not an individual report is expected/listed or unexpected/unlisted as per the US label, as well as, whether or not an individual case would likely require FDA  submission.

Safety database searching

Able to run accurate queries and provide standard outputs of the data from the safety database, if requested.  Performs searches of the safety database for internal compliance or other ad hoc queries, as required.

Reconciliation of safety data

As assigned, performs monthly reconciliations with partners/affiliates, Medical Information and QA.

Review and Update of Departmental documents

Assists in development, review, and implementation of Product Safety working practices, standard operating procedures (SOPs), or guidance documents to ensure compliance with international regulations