zachodniopomorskie / Szczecin

Vigilance Specialist

wczoraj

Miejsce pracy: Szczecin

Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we have our Business Centre that works with global financial operations, orders administration, HR and IT support, Legal & Business Ethics, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here!

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

Your qualifications:

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.

We offer:

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

Thats not all! We have even more for you:

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

If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.

By clicking the "Apply" or "Apply Now" button or by sending a recruitment application otherwise to Coloplast Business Centre Sp. z o.o., you agree for processing of your personal data for recruitment purposes in accordance with art. 6 par. 1 point b and f of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and of the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). You also agree to the processing of personal data included in the application form for future recruitments by Coloplast Business Center Sp. z o.o.
The administrator of personal data is Coloplast Business Center Sp. z o.o . with registered office in Szczecin, ul. Piastów 30, 70-064 Szczecin; contact to the Data Protection Officer: dataprotectionoffice@coloplast.com.
In addition, we would like to inform that:
Your personal data will be processed up to six months from the completion of the recruitment process.
You have the right to request access to your personal data, its rectification, erasure or limitation of processing and the right to object to processing, as well as the right to data portability.
You have the right to withdraw your consent at any time. The above does not affect the lawfulness of processing which was carried out on the basis of your consent before it was withdrawn.
You have the right to lodge a complaint with a supervisory authority - the President of the Office for Personal Data Protection.
Providing your personal data by yourself is voluntary, but necessary to participate in the recruitment process.
Decisions regarding the recruitment and selection process will not be taken in an automated manner.