Pharmacovigilance Scientist
the organization
For our Drug Safety & Pharmacovigilance department based in the Netherlands, we are looking for a Pharmacovigilance Scientist (Fixed term).Job description
Within your Therapeutic Area you have to ensure an adequate safety component of all Astellas studies for assigned products. You will participate in the study team where you are responsible for the scientific input of the safety aspects and coordination of the medical aspects during the conduct of the study. Within the study team you will coordinate safety-aspects of the study, including but not limited to periodic safety reports, SAE reporting plans and reconciliation. You will serve as a liaison regarding study-related and other pharmacovigilance information for assigned products. Outside the context of the clinical studies you will work closely with the Pharmacovigilance Physician within your assigned Therapeutic Area in contributing towards signal detection, signal evaluation and risk management. You will support with the creation of periodic and ad hoc safety reports, including health authority requests and support in PV inspections and audits.Job requirements
• University education with (para)medical back ground• 3-4 years of previous and/or clinical experience in pharmaceutical industry (in particular Drug Safety)
• Excellent communication skills, both verbally and written English
• Knowledge of Microsoft Office
• Influencing and negotiation skills
• Able to make accurate assessments
• Able to work under time pressure and adapt to unpredictable situations
• Special sense for safety issues
