Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, apply with us today!  

Job Description

The Pharmacovigilance (PV) Case Quality Check (CQC) Specialist plays a critical role in ensuring the accuracy, completeness, and compliance of pharmacovigilance cases. This position involves meticulous review and validation of safety data and documentation to guarantee adherence to regulatory requirements and internal standards. The specialist will collaborate with cross-functional teams to identify and rectify discrepancies, contributing to the overall quality of pharmacovigilance processes. 

Essential Duties and Responsibilities

• Conduct comprehensive reviews of the assigned the PV cases, following process requirements and alignment with the CQC Lead.

• Verify the consistency, accuracy and completeness of the data entered in the global PV, adhering to the regulatory requirements and internal procedures.

• Document the identified errors or inconsistencies in alignment as per the process requirements.

• Provide feedback for case corrections to countries / country Point of Contact (POC).

• Support maintaining a focus on quality in process delivery.

• Implement communicated functional and operational process changes, requirements, and feedbacks in day-today operations.

• Timely notify and escalate any identified gaps, trends observed during conduct of CQC, areas of improvement, or process-related feedback or requests received from internal or external stakeholders to the CQC Lead.

• Actively collaborate and consult with the CQC Lead to address and resolve these issues in a timely manner.

• Collaborate with the CQC Lead to support the development and maintenance of the process standards and outputs. Contribute to continuous improvement initiatives, as needed.

• Seek opportunities to improve the overall quality of case reviews by incorporating feedback into daily CQC to meet the expected quality standard.

• Assist the CQC Lead during audits and regulatory inspections to the extent agreed and as required.

• Assist CQC Lead in planning corrective/preventive actions, as applicable.

• Participate in various meetings and discussions, as applicable, contributing in alignment with the CQC Lead.

QualificationsBachelor's degree in life sciences, animal health, veterinary medical technology, veterinary medicine, nursing, pharmacy, biochemistry, zoology or a related discipline. Master’s degree is a plus.3 to 5 years of experience in the pharmaceutical/biotechnology area and/or quality-related areaExperience in the pharmaceutical industry within the regulated area of pharmacovigilance.Experience with case data entry in applicable PV database and/or case quality requirements is preferredExperience in AI, machine learning and/or advanced MS Office would be an asset.Experience working in an international, multicultural, and transversal environment.Familiarity with GxP systems in the pharmaceutical industry, including knowledge of applicable regulations, computerized system validation, GXP principles, and practices.Familiarity with statistical, quality, and data integrity principles

Additional Information

Position is full-time, First Shift, Monday-Friday 8AM-5PM. 

Excellent full time benefits including comprehensive medical coverage, dental, and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.