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Product Safety Associate

Merz Pharmaceuticals LLC

Raleigh, NC

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Administrative Skills, Adverse Events, Biotech and Pharmaceutical, Clinical Information, Clinical Research, Communication Skills, Database Technology, Detail Oriented, Executive Assistant Skills , External Audit, FDA (Food and Drug Administration), Health Canada, Internal Audit, Interpersonal Skills, Investigational New Drug (IND), Maintain Compliance, Marketing, Medical Coding, Medical Dictionary for Regulatory Activities (MedDRA), Medical Records, Medical Terminology, Mentoring, Multitasking, Organizational Skills, Patient Care, Pharmacovigilance, Presentation/Verbal Skills, Problem Solving Skills, Process Analysis, Product Reviews, Product Safety, Project/Program Management, Quality Assurance, Reconciliation, Regulations, Regulatory Compliance, Regulatory Reports, Research & Development (R&D), Safety Data Agreements, Sales, Sales Training, Standard Operating Procedures (SOP), Team Player, Time Management, Training/Teaching, Trend Analysis, Vendor/Supplier Selection, Writing Skills
LOCATION
Raleigh, NC
POSTED
30+ days ago
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 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 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 governing clinical safety, and pharmacovigilance for adverse event reporting. Provides training regarding AE reporting As assigned, provides training to sales representatives, other employees and contractors/vendors in their obligations regarding adverse event reporting. May assist with orientation/mentoring of new Product Safety staff. Audit Support Participates in all internal and external audits, as needed. Interacts with and supports Global Safety Represents US Tx Product Safety on the global project level, as required by Global Product Safety. US PADER reports / Annual Safety Reports As assigned, assists with annual PADER reports for US Tx local products and works with Regulatory to ensure the on-time submission of the report to the FDA. AEMS (FDA) Database monitoring As assigned, assists with monitoring USA FDA AEMS, for safety data for Merz Tx products reported to health authority (HA), that were not yet reported to Merz or captured in our Merz Safety Database. As assigned, assists with monitoring of AEMS for potential safety signals reported for Merz Tx products by HA. Other duties as assigned Job related qualifications/skillsEducation - Bachelor's degree in a science or heath care-related field required Professional experience - At least 2 years pharmacovigilance experience within the pharmaceutical or device industry required. Knowledge, skills and abilities (incl. languages) - 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. Knowledge of methods - 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. Personal skills - 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. Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles. Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com

About the Company

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Merz Pharmaceuticals LLC

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