Sr. Drug Safety Scientist

Fresenius Kabi USA, LLC; Street; On-site; USD 110,000 - 130,000; Full time

Job summary

An established industry player is seeking a Sr. Drug Safety Scientist to lead the assessment and reporting of adverse drug events. This pivotal role involves collaboration with global teams to ensure compliance with regulations and quality standards. The ideal candidate will have a strong clinical background, excellent leadership skills, and a passion for patient safety. You will oversee the development of training materials and maintain current knowledge of relevant regulations. Join a forward-thinking company that values innovation and offers a competitive salary and comprehensive benefits package, including health coverage and a 401(k) plan with company contributions.

Benefits

401(k) Plan with Company Contributions

Paid Vacation

Comprehensive Health Benefits

Employee Assistance Program

Wellness Programs

Qualifications

• 8+ years of drug safety experience with a focus on adverse event reporting.
• Current medical/clinical professional degree in good standing.

Responsibilities

• Lead the processing and reporting of global adverse drug events.
• Collaborate with medical teams for review and assessment.

Skills

Drug Safety and Adverse Event Reporting

Clinical Judgment

Leadership Skills

Organizational Skills

Interpersonal Skills

Critical Thinking

Regulatory Knowledge

Teamwork

Education

PharmD, RPh, RN

Tools

Aris Global Systems

MedDRA/WHO Coding

Microsoft Office

LifeSphere MultiVigilance

Job description

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

1. Lead the receipt, assessment, follow-up, processing, and reporting of global adverse drug events in accordance with SOPs, FDA regulations, and guidelines.
2. Perform peer review in the KabiSafe LSMV database and the global complaint management workflow.
3. Collaborate with the Global Vigilance Medical Manager/PV Physician for medical review and assessment.
4. Serve as Subject Matter Expert (SME) for adverse event processing and FDA reporting; conduct interdepartmental training.
5. Lead development and maintenance of training materials.
6. Oversee preparation of PADERs and individual case safety reports.
7. Maintain current knowledge of relevant regulations, SOPs, guidelines, and product information.
8. Lead development and management of Safety Data Exchange Agreements (SDEAs) and perform ADE reconciliation activities.
9. Implement and monitor REMS programs for compliance.
10. Work with the Global Vigilance team to identify and resolve compliance issues.
11. Coordinate with Quality and Regulatory Departments to address safety and quality issues.
12. Assist in creating or revising department procedures and policies.
13. Maintain a professional and cooperative demeanor with internal and external stakeholders.
14. 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.