Freelance Engineering Consultant
il y a 2 semaines
Brussels (Belgium) – Hybrid 2 days in office
The IT CoE CSV General Application – Pharmacovigilance - Senior resource will lead, execute and supervise the CSV activities for assigned projects for the pharmacovigilance systems. The Senior CSV will act as a deputy for the IT Compliance Lead and coach for junior resources and other stakeholders
Proactively identify, in alignment with the IT Compliance Lead, the validation approach and deliverable list.
Validation requirement assessment, Validation Plan and Report, Test protocols and report, Traceability matrix. End-to-end ownership and following-up pro-actively on validation documentation and testing activities
Coordinate test execution in collaboration with IT system owner, Business Owner and testing team
Create test protocols and report (IQ/OQ/PQ/MQ)
Support the writing and execution of test scripts (IQ/OQ/PQ/MQ), with IT and business stakeholders
Be the deputy of IT Compliance Lead for project assigned and share validation status with project team
Coach junior CSV resources and other stakeholders on CSV and Compliance activities
Bachelor degree in pharma-related domain or IT-related domains
Good English speaking/writing skills, French speaker would be a plus.
Domain Skills General Pharma application GPVP eg adverse event reporting (Argus, ArisG, Veeva Safety)
General Pharma applications and Veeva knowledge is a plus
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