Pharmacovigilance Manager

For one of our clients, based in Mechelen, we are looking for a pharmacovigilance manager. 

Your Job

• Lead pharmacovigilance projects and coordinate project team activities
• Implement and administrate PV systems
• Write and update project related Safety Management Plans/Safety Data Exchange Agreements
• Ensure case Management Process
• Ensures local literature search activity
• Review and update Periodic Safety Update Reports (DSURs/PSURs/PBRERs) as/if applicable
• Under line manager supervision, interact with competent authorities as required
• Interact with clients and ensure compliance
• Contribute to the preparation of proposals as applicable in liaison with the line manager
• Participate to audits and inspections in liaison with dedicated projects
• Write and maintain up to date pharmacovigilance SOPs and instructions up to date
• Perform weekly regulatory surveillance
• Ensure compliance with the client procedures
• Contribute to the preparation of presentations, webinars, blogs and posts
• Acts as back up on other PV projects than dedicated as needed and providing appropriate transmission

Your Profile

• Pharmacist or scientific graduation
• 2 to 5 years of professional experience in the field of vigilance
• Knowledge of relevant vigilance regulations and guidelines
• Strong service orientation
• Ability to manage more than one projects with limited guidance
• Independent approach to work, flexibility and dedication
• Diplomacy, ability to communicate and integrate in an international and multicultural environment
• Strong sense of responsibility, organizational skills and motivation
• English language fluency, written and spoken
• Dutch fluency