Regulatory & Pharmacovigilance Manager, Nordics (Stockholm)

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Regulatory & Pharmacovigilance Manager

Do you want to work as Regulatory & Pharmacovigilance Manager in an entrepreneurial environment for a company that lives by its strong company values and ambitious sustainability agenda?

The Role

In this role you will be regulatory and pharmacovigilance responsible for Chiesi Nordic’s largest business unit Air&Care as well as local pharmacovigilance lead for Chiesi Nordic. The role is a mix of hand on tasks, as well as ensuring general oversight and coordination of activities, especially in the pharmacovigilance area. You will be working in close collaboration with other functions such as Marketing and Medical Affairs, as well as corporate regulatory and pharmacovigilance based at the Chiesi head quarter in Italy. The role is placed in the Pharmaceutical Affairs function, and you will be reporting to the Pharmaceutical Affairs Manager.

Key responsibilities

  • Drive the local regulatory agenda in line with business priorities, and provide regulatory expertise to collaborating functions
  • Regulatory responsible for the business unit Air&Care including products in national, MRP/DCP and centralized procedure
  • Local regulatory submissions, translation coordination and artwork updates
  • Local contact towards Nordic regulatory authorities
  • Responsible for Chiesi Nordics Pharmacovigilance processes according to applicable regulations and Chiesis global pharmacovigilance system
  • Pharmacovigilance responsible for the assigned portfolio in medical and marketing projects such as non-interventional local studies, market research, webpages, etc.
  • Handling of ICSRs
  • Quality monitoring with the pharmacovigilance area
  • Responsible for Chiesi Nordics pharmacovigilance training activities

 

Qualifications

  • University degree in Life Science, Pharmacy or similar
  • Extensive experience in Regulatory Affairs, preferably in a Nordic setting
  • Experience in pharmacovigilance
  • Fluent in oral and written English and at least one Nordic language

 

Personal profile

As a person, you are proactive, result oriented and see your role in the bigger picture. You communicate well and strive for good collaborations. You have an analytical mind and can pay good attention to details, and in addition you are able to set and keep your priorities.

Location

The position is based in the office in Stockholm city, where you are expected to be present 3 days/week.
 

Welcome with your application!

We are accepting applications on a rolling basis, so please feel free to upload your CV if you are interested!
Do not hesitate to contact us for more information.

 

About Chiesi Pharma

Chiesi is an international, research-focused biopharmaceuticals group with over 85 years of experience that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and critical care. The company´s mission is to improve people´s quality of life and act responsibly towards both the community and the environment. We are proud to have been awarded B Corp Certification, a recognition of high social and environmental standards.

The Nordic organisation started its journey in 2014 and today we engage around 100 employees across Sweden, Denmark, Finland and Norway. The Nordic office is located in the central part of Stockholm, together with a Research & Development site next to the KI campus.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Read more about Chiesi on www.chiesi.com or www.chiesipharma.se

Oplysninger om jobbet

  • Arbejdsplads

    Stockholms län
  • Sidste ansøgningsdag

    2024-03-20
Apply here

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