Drug Safety Scientist

• 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.

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.