IT CSV Senior

☞ HNM Solutions

Vue: 102

Jour de mise à jour: 22-11-2025

Localisation: Braine-l’Alleud Walloon Brabant

Catégorie: IT - Logiciel IT - Matériel / Réseaux Informatique

Industrie:

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le contenu du travail

Role: IT CSV – Senior

Location: Braine L’alleud (Belgium) – Hybrid 2 days in office

Description:

  • The IT CoE CSV General Application – Pharmacovigilance - Senior resource will lead, execute and supervise the CSV

  • activities for assigned projects for the pharmacovigilance systems at client. 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 client 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 client IT Compliance Lead

  • Be fully available and committed during an Inspection/Audit preparation and defense

  • Be the deputy of client IT Compliance Lead for project assigned and share validation status with project team

  • Direct report to the client IT Compliance Lead on personal activities via weekly meeting

  • Be part of a weekly activities review meeting with associated client IT Compliance Lead

  • Coach junior CSV resources and other stakeholders on CSV and Compliance activities

Job Qualifications:

  • Bachelor’s 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

  • o GPVP eg adverse event reporting (Argus, ArisG, Veeva Safety)

  • o GCP eg. Clinical trail monitoring (CTMS..)

  • o General Pharma applications and Veeva knowledge is a plus

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Date limite: 06-01-2026

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