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CSV Engineer | Belgium | Freelance/Contract
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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
