Product Safety Associate

Merz Group•Raleigh, NC

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a science or heath care-related field required
At least 2 years pharmacovigilance experience within the pharmaceutical or device industry required.
Excellent knowledge of regulations governing clinical safety, and pharmacovigilance required.
Working knowledge of MedDRA coding conventions to ensure proper coding of medical terms as well as a working knowledge of the WHO Drug Dictionary required.
Requires highly effective communication skills (written and oral) which are concise, accurate and business appropriate.
Good understanding of pharmaceutical research and development process. Strong knowledge and understanding of medical terminology and clinical/medical information required.
Prior safety database experience required. Ability to run accurate database searches to answer basic queries as required.
Demonstrates comprehensive understanding of product labeling and Instructions For Use required.
Maintains current knowledge of drug, biologic and drug/device combination reporting regulations worldwide.
Able to continue day to day departmental activities in absence of direct management.
Strong interpersonal, teamwork, organizational skills.
Ability to function in an environment of rapidly changing priorities with the ability to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
Ability to act independently and to take initiative as well as work within a team. Self-starter, able to work with a high degree of independence.
Demonstrated critical thinking and problem-solving skills required.

Responsibilities

Adverse Event Case Processing and Oversight
Literature review for AEs
On Time submission of AE Reports
Safety database subject matter expert (SME), assists with internal and external request for safety data
Interpretation of individual AE reports and safety data
Safety database searching
Reconciliation of safety data
Review and Update of Departmental documents
Provides training regarding AE reporting
Audit Support
Interacts with and supports Global Safety
US PADER reports / Annual Safety Reports
AEMS (FDA) Database monitoring
Other duties as assigned