Job Summary

The Sr. Drug Safety Scientist 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.

Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

• Salary Range: $110,000-$130,000
• 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. Read more about our benefits here.

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, 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.
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