Senior Pharmacovigilance Consultant overseeing QPPV office services for ProPharma clients. Implements local and global Pharmacovigilance services while supporting audits and inspections.
Responsibilities
Implements and maintains QPPV office services for ProPharma Group clients
Serves as a Subject Matter Expert (SME) for assigned PV areas.
Oversees successful service delivery from operational perspective.
Leads the creation and maintenance of Pharmacovigilance System Master File.
Management of activities related to clinical trials.
Provides feedback and updates to current QMS documentation relevant for the QPPV office process.
Develops and delivers PV training.
Supports client audits and inspections.
Requirements
University Degree (BSc EQF level 6, MSc EQF level 7, or PhD EQF level 8), in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life science, medical technology or biology.
Minimum of 4 years’ experience in clinical and/or post-marketing pharmacovigilance
Strong knowledge of EU PV legislation and guidance.
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