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 7 highly skilled specialists, 4 working in Quality Reporting dedicated for Complaint, Nonconformities, Supplier Quality and Sustainability areas, 1 is Project Management Office Specialist and 2 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 4 people in total. 
 
Your new job in Coloplast
Your main responsibilities will be to diligently investigate incidents and report to national competent authorities according to applicable regulatory guidelines and timelines. Furthermore, you will create PSUR and PMS reports, handle safety issues related to the use of our products and deliver vigilance data for the registration of products in new markets.
 
Your key responsibilities:
Your main task is to be the specialist in handling vigilance cases, including investigating with colleagues in various parts of Coloplast – for example Medical Affairs and Manufacturing Sites, and creating reports to authorities. Furthermore, you will:  

• Interact with authorities to fulfill the regulatory requirements related to vigilance for Coloplast products (e.g. reporting of serious incidents and Field Safety Corrective Actions)
• Effectively communicate vigilance regulatory requirements throughout Coloplast
• Follow worldwide regulatory development of the vigilance framework
• Interact with stakeholders throughout Coloplast and provide vigilance training for relevant Coloplast departments and subsidiaries

You have a degree in pharmacy, life science, public health, nursing or similar. Preferably, you have Vigilance or Regulatory experience from the medical device or pharma industry.
 Furthermore, you:

• Are structured, disciplined and know how to drive a vigilance process forward
• Have the ability to keep the overview and be decisive even with several cases on-going at once
• Have knowledge of regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, and FDA 21 CFR 820.30
• Have strong communication skills and are fluent in English – both verbal and written.

On a personal note you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines.  You enjoy working with multiple tasks at the same time and are analytical and capable of digesting complex data without losing the overall picture.

• No probation period – long-term contract from the start
• Remote work possibility for those outside of Szczecin
• 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 

That's not all! We have even more for you:

• Modern workplace
• No dress code zone
• Delicious coffee and fresh fruits
• Transportation co-funding