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