The posting
Job Summary
Serves as operational lead responsible for receiving, assessing, obtaining follow-up, processing, and reporting adverse drug events regarding company pharmaceutical, nutrition, and biological products. Participates in global data exchange with the Fresenius Kabi entities and other Fresenius Kabi USA partners. Interacts with the Quality and Regulatory departments to resolve safety and quality issues.
Salary Range $133,000 -$146,000 based on experience • Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Hybrid role: Onsite 3 days per week
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
Responsibilities
Serves as operational lead responsible for receiving, assessing, obtaining follow-up, processing, and reporting global adverse drug events regarding company drug products in accordance with global and local standard operating procedures (SOPs), and FDA regulations and guidelines. Responsible for peer review in KabiSafe LSMV database and the Global Complaint Management Workflow (gCMW) for all Drug Safety Scientists and Data Specialists. Liaises with the Global Vigilance Medical Manager/PV Physician to ensure that appropriate medical review and assessment is provided. Functions as Subject Matter Expert (SME) for the Vigilance Department on Adverse Drug Event (ADE) processing and FDA reporting. Conducts interdepartmental training on adverse event procedure. May lead the planning, development, and maintenance of training and associated materials. Oversight for the preparation of Periodic Adverse Drug Experience Reports (PADER) and individual case safety reports. Maintains current knowledge of applicable local and global regulations, standard operating procedures, and guidelines. Maintains an in-depth understanding of product knowledge, labeling, and relevant data for company products. Maintains knowledge of all pertinent regulatory safety publications. May lead the development, implementation, and management of Safety Data Exchange Agreements (SDEAs) and performs ADE reconciliation activities with Partners per Safety Data Exchange Agreement (SDEA). May lead the implementation and monitoring of REMS programs, ensuring compliance with regulatory requirements. Collaborates with the Global Vigilance team to identify potential compliance issues with case processing and discuss solutions to maintain compliance. Interacts with the Quality and Regulatory Departments, as needed, to resolve safety and quality issues. Assists in the creation/revision of department procedures and policies. Interacts with a compassionate, courteous, cheerful, and cooperative demeanor at all times with both internal and external customers in accordance with Fresenius Kabi values. Additional tasks and responsibilities as required.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Requirements
- Current medical/clinical professional degree in good standing required (i.e., PharmD, RPh, RN).
- Dynamic highly motivated professional with the ability to work cross-functionally and collaboratively.
- Minimum of 8 years of drug safety and adverse drug event reporting experience required.
- Clinical/hospital experience preferred.
- Strong organizational, management, teamwork, interpersonal skills, and professionalism required.
- Adverse drug event reporting experience required. Pharmaceutical industry experience in post marketing setting preferred.
- Experience with preparation of Periodic Adverse Drug Experience Reports (PADER) is preferred.
- Experience with management of SDEAs preferred.
- Experience with REMS operations and compliance preferred.
- Excellent clinical judgment and critical thinking skills required.
- Demonstrates leadership skills with a focus on solution-based ideas.
- Takes initiative and is able to perform duties with minimal supervision.
- Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
- Ability to gather data from multiple sources and references and formulate a medically appropriate case narrative.
- Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
- Must be able to prioritize and multi-task with minimal supervision and participate in peer-review process when processing product complaints and adverse drug events.
- Knowledge of Aris global systems, MedDRA/WHO drug coding, and Microsoft Office Suite (Word, Excel, PowerPoint) required. LifeSphere® MultiVigilance experience preferred.
- The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
