Sr. Drug Safety Scientist

Job Summary The Sr. Drug Safety Scientist serves as the operational lead responsible for receiving, assessing, obtaining follow-up, processing, and reporting adverse drug events related to company pharmaceutical, nutrition, and biological products. They participate in global data exchange with Fresenius Kabi entities and other partners, and interact with Quality and Regulatory departments to resolve safety and quality issues. Due to applicable export control laws and regulations, candidates must be U.S. citizens or nationals, U.S. permanent residents (Green Card holders), or lawfully admitted into the U.S. as refugees or granted asylum. Salary Range: $110,000-$130,000 Additional Compensation: Eligible for a bonus plan with a target of 10% of base salary (if applicable). Final pay depends on experience, education, knowledge, skills, and abilities. Our benefits include a 401(k) plan with company contributions, paid vacation, holidays, personal days, an employee assistance program, and comprehensive health benefits covering medical, prescription drugs, dental, and vision. More details can be found here . Responsibilities Lead the receipt, assessment, follow-up, processing, and reporting of global adverse drug events in accordance with SOPs, FDA regulations, and guidelines. Perform peer review in the KabiSafe LSMV database and the global complaint management workflow. Collaborate with the Global Vigilance Medical Manager/PV Physician for medical review and assessment. Serve as Subject Matter Expert (SME) for adverse event processing and FDA reporting; conduct interdepartmental training. Lead development and maintenance of training materials. Oversee preparation of PADERs and individual case safety reports. Maintain current knowledge of relevant regulations, SOPs, guidelines, and product information. Lead development and management of Safety Data Exchange Agreements (SDEAs) and perform ADE reconciliation activities. Implement and monitor REMS programs for compliance. Work with the Global Vigilance team to identify and resolve compliance issues. Coordinate with Quality and Regulatory Departments to address safety and quality issues. Assist in creating or revising department procedures and policies. Maintain a professional and cooperative demeanor with internal and external stakeholders. Perform additional tasks as required, ensuring compliance with health, safety, environment, energy, and quality management systems. Requirements Current medical/clinical professional degree (e.g., PharmD, RPh, RN) in good standing. Minimum of 8 years of drug safety and adverse event reporting experience. Clinical or hospital experience preferred. Strong organizational, management, teamwork, interpersonal skills, and professionalism. Experience with adverse drug event reporting, post-marketing pharmaceutical industry experience preferred. Experience with PADERs, SDEAs, and REMS operations is preferred. Excellent clinical judgment, critical thinking, and leadership skills. Ability to work independently, interpret regulations, gather and analyze data, and recognize health hazards. Proficiency with Aris global systems, MedDRA/WHO coding, Microsoft Office; LifeSphere MultiVigilance experience preferred. Excellent written and verbal communication skills. Additional Information We offer a competitive salary and benefits package including health coverage, life insurance, disability, 401(k) with company contributions, and wellness programs. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or veteran status. #J-18808-Ljbffr