Patient Safety Associate
11 godzin temu
Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being.
Our European branch is present in 30 countries with a strong local anchorage, originating from the former Omega Pharma.
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.
Job OverviewWe are seeking a Patient Safety Associate to join our team in Ghent, Belgium or Warsaw, Poland.
This role will be responsible for day-to-day functions concerning case handling, triaging, and assigning priorities for processing adverse events and safety relevant information.
The ideal candidate will have a Life Science Degree, adverse event handling and/or prior MedDRA coding experience, and knowledge of medical terminology and International Regulations such as EU Good Pharmacovigilance Practices and EU Medical Device Regulations.
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
- 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
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.
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.
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.
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