Patient Safety Associate (OTC / Medical Devices) 1

Location:

(02-653) Warsaw, Masovian, Poland

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Science Jobs

Advertiser:

Perrigo

Job ID:

131491913

Posted On:

09 January 2025

 

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill(R), Compeed(R), Solpadeine(R), NiQuitin(R), ACO(R), and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.

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
-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

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo. 

Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of “America’s Best Employers by State 2024”. Find out more here

Applicants please note:  to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.)  Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.  Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo

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