Vigilance & PMS Specialist

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Are you keen to work with user safety? Want to work with both internal and external stakeholders around the world? Then join us in our mission to make life easier for people with intimate healthcare conditions.

We seek a resourceful and proactive Vigilance Specialist
The position as Vigilance & PMS Specialist is vital to Coloplast’s way of doing business. Our license to sell, relies, among other things, on our ability to assess complaints from customers and report in a timely manner to the authorities, to ensure we meet regulatory requirements. Therefore, you, as our Vigilance & PMS Specialist, play a major part in making this come true.

Join our Quality Process department
The position is located in our headquarter in Humlebæk. Joining us, you will be part of a hybrid team of 4 Vigilance specialists, where 2 are in headquarter and 2 are associated with our business centre in Poland. In headquarter you will be part of PMS, Systems & Processes, a department of 10 highly qualified colleagues supporting different aspects of quality. Together, we are responsible for bringing expert knowledge on core quality processes, including Vigilance and post market surveillance, into the entire Coloplast organisation.

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 post market surveillance documents, like PSUR and PMS reports.

Your key responsibilities:

• Assess incidents for reportability, using stakeholders from e.g. subsidiaries in countries around the world, Medical Affairs, Product Support, and manufacturing sites
• Create manufacturers’ incident reports to authorities
• Interact with authorities to answer requests
• Deliver vigilance data for registration of products in new markets
• Handle requests from authorities
• Lead the task force for safety related issues, and handle field safety corrective actions, when needed
• Own procedures and instructions related vigilance and PMS in our QMS
• 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, or nursing
• have vigilance or regulatory experience from the medical device or pharma industry
• are structured, disciplined and know how to drive a vigilance process forward
• can 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 verbally and in writing

As a person, 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, are analytical and capable of digesting complex data without losing the overall picture.

Interested?
If you would like to know more about the position, please write to Head of Post Market Surveillance, Systems and Processes, Lotte Dock Steenstrup at [email protected]. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 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.

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