GPV

Job Title:

GPV

Location:

new york NY US 10020

Location Type:

Remote

Basic Qualifications:

• Bachelors degree in Life Sciences or related field

Experience Range:

• Overall experience - 2 to 5 years

Required Skills:

• Pharmacovigilance

• GxP

• UAT

• CSV

• Test Case Design

• Defect Management

• Regulatory Compliance

Preferred Qualifications:

• SAP

• Workday

• GVP

• FDA

• PMDA

• Life Science domain experience

Roles and responsibilities:

Conduct pharmacovigilance application testing, ensure GxP and CSV compliance, facilitate UAT and defect management, coordinate with business SMEs, document evidence and support regulatory requirements.

Job description:

• Perform functional and validated application testing in the pharmacovigilance domain.

• Design and execute test cases ensuring GxP, CSV, and CSA compliance.

• Facilitate UAT and manage the defect lifecycle with thorough documentation.

• Coordinate with business SMEs to ensure requirement traceability and regulatory alignment.

• Document evidence and support regulatory audits with strong analytical and compliance skills.