Emplois en direct

The Senior CSV Specialist will lead and supervise CSV activities for pharmacovigilance systems projects, acting as a deputy to the IT Compliance Lead and coaching junior resources.

Key Responsibilities:

• Lead and execute validation activities for assigned projects.
• Identify and manage validation deliverables.
• Author and review CSV documents (plans, reports, test protocols).
• Coordinate test execution with stakeholders.
• Create and monitor deviations and corrective actions.
• Be available for audit preparations and defenses.
• Coach junior resources on CSV and compliance activities.

Qualifications:

• Bachelor’s degree in a pharma-related or IT-related field.
• Minimum of 8 years of experience in CSV project management.
• Strong communication and negotiation skills.
• Proficient in English; French is a plus.
• Ability to work autonomously and prioritize tasks in a fast-paced environment.

Specific Skills:

• Experience with pharma applications (GPvP, GCP, Veeva).
• Knowledge of pharmacovigilance systems and computerized system validation.