Patient Safety Associate (OTC / Medical Devices)

Location:

(02-653) Warsaw, Masovian, Poland

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Science Jobs

Advertiser:

Perrigo

Job ID:

131244249

Posted On: 

18 October 2024

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

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