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