PV Specialist

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Hørsholm

Is patient safety important for you?



The position

Are you curious to understand how we improve the life for people suffering from allergies?

Do you want to contribute to the pharmacovigilance (PV) function and systems at ALK?

ALK Global Pharmacovigilance (GPV) is responsible for monitoring of the safety aspects of all ALK medicinal products and medical devices. We have an open position in the team supporting the Qualified Person responsible for Pharmacovigilance (QPPV) and we are offering a position as PV Specialist in the QPPV Office with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies.


Fields of responsibility


As PV Specialist your key focus is to contribute to the ALK global PV system, and supporting the Head of the QPPV Office and the QPPV with main tasks being:

  • Contribute to oversight, development and maintenance of ALK GPV quality system, including quality documents governance and PV systems in general
  • Contribute to compliance management and oversight of affiliates and external stakeholders
  • Lead and participate in PV development projects
  • Contribute to and review of key PV documents from audits and inspections including providing support during PV audits
  • Manage the negotiation, implementation and maintenance of Pharmacovigilance Agreements with ALK contractual partners
  • Contribute to PV training of staff in headquarter, affiliates, and external parties
  • Provide support to affiliates as needed on a day-to-day basis
  • Take part in conferences and seminars in order to stay alert regarding legislation (nationally and internationally) concerning PV

Your qualifications

  • Relevant educational degree within life science, e.g. nurse, human biologist, pharmacist, MD
  • Solid theoretical and practical PV knowledge: minimum of 3 years of experience within PV (e.g. operation, surveillance, quality). This includes solid knowledge and understanding of international clinical and post-marketing PV regulations and guidelines
  • Possess strong communication and analytical skills
  • Can work independently as well as collaboratively with other team members and stakeholders
  • Have an innovative, proactive, result- and goal-oriented mindset
  • Fluency in spoken as well as written English
  • Experienced PC-user
  • Outgoing personality, with excellent negotiation and relation building skills


The department/team


The QPPV Office team is comprised of 4 dedicated and passionate professionals (pharmacist, nurses, MD) and is based at ALK headquarter in Hørsholm. The QPPV Office team is part of GPV which consists of +30 passionate colleagues located in Denmark, Spain and US. We are striving to efficiently communicate and manage risk throughout the life cycle of our products to ensure an optimal benefit/risk profile of all ALK products. We do that by an on-going proactive risk management approach constantly improving the quality of our processes and developing our competencies to always meeting the need of the patients and other stakeholders as we think people with allergies first.

We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.


Allergy Solutions for Life


More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.

By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.

We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast track to a more balanced life.

By joining ALK, you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.

If this sounds like a mission, you also would like to be part of we hope to receive your CV and application.


Contact


For further information on the position please contact Andreas Holst (AHTIT), Head of QPPV Office @ +45 40 56 25 60.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Hørsholm.

Jobbet er oprettet på vores service den 17.6.2020, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Hørsholm

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