Job Description
Job Summary
Salary Range: $100,000.00 to $110,000.00 per Yr
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.
Please note: This position does not support employment sponsorship, either now or in the future. Candidates must be legally authorized to work in the United States at the time of application and remain so without the need for current or future visa sponsorship.
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
Receives, assesses, obtains follow-up, processes, and reports adverse drug events regarding company drug products. Participates in global data exchange with Fresenius Kabi entities and other Fresenius Kabi USA partners. Interacts with the Quality and Regulatory Departments to resolve safety and quality issues.
Responsibilities
- Receives , assesses, processes, and obtains follow-up for adverse drug events in accordance with global and local regulations and SOPs.
- Manages preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance and coordinate timely FDA submissions with Quality and Regulatory Departments.
- Collaborates with the Quality team to resolve safety and quality issues.
- Performs complex ADE case processing.
- Performs 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
- Holds a current medical/clinical professional degree in good standing required i.e., PharmD, RPh, RN degree.
- Minimum 3 years of drug safety and adverse drug event reporting experience required.
- Experience with preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) is preferred Clinical/hospital experience preferred.
- Demonstrated ability to interpret and apply FDA regulations, global and local safety guidelines, and internal SOPs to the assessment and processing of adverse drug events, including identification of potential product quality issues.
Proficiency in gathering and evaluating data from multiple medical and regulatory sources to develop accurate and medically sound case narratives. - Experience with Aris Global systems is a plus. Dynamic highly motivated professional with the ability to work cross-functionally and collaboratively
Ability to analyze safety and quality-related data to identify potential health risks (signal detection).
Working knowledge of PC-based systems, adverse event safety databases, and Microsoft Office applications. - Strong critical thinking and problem-solving abilities; able to work independently while effectively managing multiple priorities.
- Ability to collaborate cross-functionally and participate in peer review processes.
- Maintains a high level of attention to detail while performing complex case assessments.
- Demonstrates professionalism and interpersonal effectiveness consistent with company values.
- Excellent written and verbal communication skills required.
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, andwellness program.
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.
Job Tags
Work at office, Local area,