PMS Referent
About the Position:
Post marketing surveillance
Do you have a keen eye for detail and the capacity to learn quickly? Come join our PMS team! We are seeking a dedicated and detail-oriented Post Marketing Surveillance Referent to join our PMS team on the QA department. This role involves monitoring the safety and efficacy of our products post-market release. By meticulously analyzing and reporting adverse events, you will contribute significantly to protecting patient health and maintaining regulatory compliance.
What responsibilities will you have?
Sorting and processing returned products (used/non-used goods) on the Priority system
Inspection of non-used goods returns.
Identifying exceptional cases and reporting them to the team leader.
Handling field actions/possible field actions.
Filling and documenting internal forms.
Communication, when needed, with sales departments, R&D, QE etc. regarding field safety notifications or recalls.
Examining reporting requirements for authorities.
Tracking and monitor PMS KPI's.
Opening ECO as needed and updating procedures.
You will be a perfect fit for this role if you meet the following requirements:
Critical Knowledge and Qualifications:
- Bachelor's degree- advantage.
- QA experience- advantage.
- Problem solving skills.
- Being able to assess possible solutions, while receiving a moderate level of guidance & instructions.
- Quick learning about our company, our customers & internal processes.
- Requires expanded conceptual knowledge in own discipline and broadens capabilities.
- Proficiency in Microsoft Office Suite (Outlook, Excel, Word).
- Strong written and verbal communication skills in English.
Critical Skills/technical know-how:
- Solid Works, PDM vault.
- Ability to write experimental reports in English.
- Ability to read and understand scientific studies in English.
Critical Experience:
- Experience as a CNC machining operator or plastic molding operator.
By combining these skills, you will be instrumental in ensuring the safety and efficacy of our products!