Senior Drug Safety Scientist

Serve as operational lead for receiving, assessing, obtaining follow-up, processing, and reporting global adverse drug events Conduct peer review in the KabiSafe LSMV database and Global Complaint Management Workflow for Drug Safety Scientists and Data Specialists Liaise with the Global Vigilance Medical Manager/PV Physician for medical review and assessment Act as Subject Matter Expert for adverse drug event processing and FDA reporting Conduct interdepartmental training on adverse event procedures Lead planning, development, and maintenance of training materials as needed Oversee preparation of Periodic Adverse Drug Experience Reports and individual case safety reports Maintain knowledge of regulations, SOPs, guidelines, product labeling, regulatory safety publications, and company product data Lead development, implementation, and management of Safety Data Exchange Agreements and perform ADE reconciliation activities as needed Lead implementation and monitoring of REMS programs as needed Collaborate with Global Vigilance to identify and resolve case-processing compliance issues Interact with Quality and Regulatory Departments to resolve safety and quality issues Assist in creating and revising department procedures and policies Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems Perform additional tasks and responsibilities as required Requirements Current medical/clinical professional degree in good standing required, such as PharmD, RPh, or RN Minimum of 8 years of drug safety and adverse drug event reporting experience required Ability to work cross-functionally and collaboratively Clinical/hospital experience preferred Strong organizational, management, teamwork, interpersonal, and professionalism skills required Adverse drug event reporting experience required Pharmaceutical industry experience in a post-marketing setting preferred Experience preparing Periodic Adverse Drug Experience Reports preferred Experience managing Safety Data Exchange Agreements preferred Experience with REMS operations and compliance preferred Excellent clinical judgment and critical thinking skills required Leadership skills with a focus on solution-based ideas Initiative and ability to perform duties with minimal supervision Ability to understand and interpret federal regulations and company operating procedures for medically complex adverse drug events Ability to determine whether adverse events suggest a product quality issue Ability to gather data from multiple sources and formulate medically appropriate case narratives Ability to interpret safety and quality-related data and identify potential health hazards through signal detection Ability to prioritize and multitask with minimal supervision Ability to participate in peer review 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 Must effectively speak, read, write, and understand English Must be authorized to work for any employer in the United States Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa Core Competencies Demonstrates expertise in adverse drug event processing, FDA reporting, and regulatory compliance, with a strong focus on collaboration and training within cross-functional teams. Proficient in preparing safety reports and managing Safety Data Exchange Agreements while ensuring adherence to industry regulations and guidelines. Highest-signal resume keywords Adverse Drug Event Reporting Safety Data Exchange Agreements Management Periodic Adverse Drug Experience Reports Preparation REMS Operations and Compliance Clinical Judgment and Critical Thinking ATS Optimization Keywords Hard Skills Adverse Drug Event Processing FDA Reporting Regulatory Compliance Data Analysis MedDRA/WHO Drug Coding Soft Skills Organizational Skills Teamwork Interpersonal Skills Leadership Skills Professionalism Certifications & Qualifications PharmD RPh RN Industry Keywords Pharmaceutical Industry Post-Marketing Setting Global Vigilance Health and Safety Regulations Quality Management Systems Tools & Technologies KabiSafe LSMV Database Microsoft Office Suite LifeSphere MultiVigilance Aris Global Systems #J-18808-Ljbffr Jobtailor