CSV Engineer

Job Title: CSV Engineer

Domain: General Application - Pharmacovigilance

Location: Brussels (Belgium) – Hybrid 2 days in office

Job Summary:

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

• Lead and execute validation activities and deliverables on assigned Changes and Projects
• Proactively identify, in alignment with the IT Compliance Lead, the validation approach and deliverable list.
• Responsible for authoring, facilitating, reviewing any CSV deliverable as per the RACI matrix: authors amongst others: Validation requirement assessment, Validation Plan and Report, Test protocols and report, Traceability matrix. Facilitate all other deliverables
• Responsible for the sequencing and monitoring of deliverable completion
• 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
• Creates, facilitates and monitor Deviations and related actions (investigations, CAPA…)
• Escalate any issues or delay to the IT Compliance Lead
• Be fully available and committed during an Inspection/Audit preparation and defense
• Be the deputy of IT Compliance Lead for project assigned and share validation status with project team
• Direct report to the IT Compliance Lead on personal activities via weekly meeting
• Be part of a weekly activities review meeting with associated IT Compliance Lead
• Coach junior CSV resources and other stakeholders on CSV and Compliance activities

Job Qualifications:

Bachelor degree in pharma-related domain or IT-related domains

Specific Skills:

• Good experience working and handling CSV Projects, minimum 8 years.
• Diplomatic, good communication and negotiation skills.
• Good English speaking/writing skills, French speaker would be a plus.
• Stakeholder management.
• Proactive and motivated. Dynamic and Hands-on
• Able to work in autonomous mode.
• Strong analytical and problem-solving skills
• Ability to work in a fast-paced, operational environment and successfully prioritize important tasks

1. Domain Skills General Pharma application GPVP eg adverse event reporting (Argus, ArisG, Veeva Safety)
2. GCP eg. Clinical trail monitoring (CTMS..)
3. General Pharma applications and Veeva knowledge is a plus