Veterinary Pharmacovigilance Case Quality Check Specialist
Veterinary Pharmacovigilance Case Quality Check Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
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 crossfunctional 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 daytoday operations.
Timely notify and escalate any identified gaps trends observed during conduct of CQC areas of improvement or processrelated 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.
Qualifications :
- Bachelors degree in life sciences animal health veterinary medical technology veterinary medicine nursing pharmacy biochemistry zoology or a related discipline. Masters degree is a plus.
- Veterinary background strongly preferred
- Signal detection experience strongly preferred
- 3 to 5 years of experience in the pharmaceutical/biotechnology area and/or qualityrelated area
- Experience 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 preferred
- Experience 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 fulltime First Shift MondayFriday 8AM5PM.
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
#LIEB1
Eurofins USA PSS Insourcing Solutions is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
