Patient Safety Associate (OTC/Medical Devices)

Description Overview

Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being.
Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. 

You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd.
Perrigo is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. 

Location: Ghent, Belgium or Warsaw, Poland

Scope of the Role

Your Responsibilities:

• Responsible for day-to-day functions concerning case handling (processing, assessment for reporting and investigation of adverse events and safety relevant information) of a diverse product portfolio (medicines, medical devices, food supplements and cosmetics)
• Performing triaging and assigning priorities for processing adverse events and safety relevant information 
• Conducting data entry and appropriate coding of adverse events and safety relevant information into the electronical complaints management system(s)
• Evaluating adverse events and safety relevant information as per the applicable regulatory requirements (including but not limited to assessment for reporting, causality and expectedness determination)
• Initiating follow-up requests considering case evaluation
• Dispatching of cases to license partners and coordinating the communication with the partners until completion
• Preparation and timely submission of adverse events and safety relevant information to Health Authorities, Authorized Representatives, Notified Bodies and safety partners
• Performing reconciliation with license partners and local safety units Providing input on case management operations for creation of training material and working instructions
• Maintaining knowledge of current regulatory requirements and standards and supporting the implementation into the company practices
   

Experience Required

Your Qualificatios:

• Life Science Degree
• Adverse event handling and/or prior MedDRA coding experience preferred
• Knowledge of medical terminology
• Knowledge of International Regulations such as EU Good Pharmacovigilance Practices, EU Medical Device Regulations (EU 2017/745)
• Detail oriented
• Fluent in English, other languages are an asset
• Ability to manage workload and meet strict deadlines
• Proficient computer skills such as complaints databases (e.g. Argus), MS Office