Drug Safety Scientist

Receives, assesses, obtains follow-up, and performs case intake for adverse drug events in accordance with global and local regulations and SOPs.

Oversees preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) with Global Vigilance and coordinates timely FDA submissions with Regulatory Departments.

Collaborates cross-functionally with internal and external teams and stakeholders.

Performs complex ADE case intake and performs quality check for submission to regulatory authority

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

• Minimum 3 years of drug safety and adverse drug safety reporting experience preferred.
• Holds a current medical/clinical professional degree in good standing required i.e. Pharm D, RPH, RN degree.
• 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.
• Experience with preparation of adverse event Periodic Adverse Drug Experience Reports (PADER) is preferred.
• 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.

• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.