(Junior) Vigilance Specialist
About the department
The job is located in Coloplast Business Centre in Szczecin, Poland. You will be a part of Quality Reporting team, a part of Global Operations Support department. The team consists of 9 highly skilled specialists, 4 working in Quality Reporting dedicated for Complaint, Nonconformities, Supplier Quality and Sustainability areas, 1 is Project Management Office Specialist and 4 are working in Vigilance area. You will support the Vigilance team within Post Market Surveillance & Quality Processes, a department within Global Quality & Regulatory Affairs located in Denmark. All your tasks and training will be coordinated from this team. The Danish team consists of 2 Vigilance specialists, which makes the Vigilance team 6 people in total.
About the job
(Junior)Vigilance Specialist is responsible for independently managing vigilance cases from intake through investigation and reporting. This includes assessing reportability, preparing and submitting regulatory reports to competent authorities, and contributing to post-market surveillance activities such as trend analysis and CAPA. Role involves cross-functional collaboration to ensure timely and compliant vigilance handling.
- Verify and manage Vigilance Review Required (VRR) complaints.
- Conduct Adverse Event Reporting (AER) and ensure timely submission to the competent authorities.
- Perform trend analyses and provide insights to product owners to drive continuous improvement.
- Contribute to the preparation and maintenance of periodic reports (PSUR, PMSR, PRER), ensuring alignment with regulatory expectations and product performance data.
- Support the creation, maintenance, and review of Post-Market Surveillance (PMS) Plans, ensuring consistency with product risk profiles and regulatory requirements; document all updates in the change control system in accordance with internal procedures.
- Assist in the assessment, documentation, and regulatory communication of Field Safety Corrective Actions (FSCA) and product recalls, in alignment with internal procedures and applicable regulatory requirements.
- Contribute to product risk reassessments.
- Develop and update relevant PMS procedures (including Vigilance) in a timely manner.
- Complete Vigilance Profile Reports (VPR) as requested by Regulatory Affairs
You have a degree in pharmacy, life science, public health, nursing or similar and you have Vigilance or Regulatory experience from the medical device or pharma industry working with VRR complaints.
- Have solid understanding of medical device regulations and vigilance processes.
- Have solid knowledge of medical terminology and/or clinical documentation.
- Have knowledge of relevant standards and legislation (ISO13485, Medical Device Regulation, FDA-part 820, Health Canada Device regulations, Japanese QMS for Devices) with special focus on regulations for Vigilance.
- Have experience with Regulatory Reporting and Vigilance platforms.
- No probation period – long-term contract from the start.
- Hybrid or remote type of work.
- Flexible working hours, Mon-Fri.
- International work environment with Scandinavian culture.
- Opportunity to use and develop foreign languages in daily work.
- Fantastic work atmosphere full of respect and partnership.
- Internal trainings.
- Great company events.
- Sports card.
- Private medical care.
- Restaurant card.
- Holiday bonus and occasional cards.
- Modern workplace.
- No dress code zone.
- Delicious coffee and fresh fruits.
- Transportation co-funding.