Deputy EU-QPPV
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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 Deputy QPPV located within the ALK QPPV Office in Hørsholm (headquarter) with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies.
Fields of responsibility
As Deputy QPPV your key focus is to contribute to the ALK global PV system, and supporting the QPPV with main tasks such as:
Your qualifications
Moreover, you have the following personal skills:
The department/team
The QPPV Office team is comprised of 7 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 +35 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 our 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 Klaus Bitsch-Jensen, Head of QPPV Office & EU-QPPV @ +45 41 95 90 30.
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 Deputy QPPV located within the ALK QPPV Office in Hørsholm (headquarter) with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies.
Fields of responsibility
As Deputy QPPV your key focus is to contribute to the ALK global PV system, and supporting the QPPV with main tasks such as:
- Contributing to the oversight, development, and maintenance of ALK’s PV procedures and policies working closely with global stakeholders
- Contributing to the maintenance of the Pharmacovigilance System Master File (PSMF) to ensure that it is constantly up-to-date, accurate, and reflects ALK’s current PV system
- Contributing to compliance management and oversight of affiliates and external stakeholdersReviewing CAPAs resulted from inspections, audits, and compliance monitoring by working closely with Global QA and other internal and external stakeholders
- Managing the negotiation, implementation, compliance oversight, and maintenance of PV Agreements with ALK’s contractual partners and service providers
- Contributing to PV training of staff in headquarter, affiliates, and external parties
- Providing support to affiliates as needed on a day-to-day basis and ensuring alignment with corporate procedures and processes
- Keeping abreast of global PV regulations, guidelines, methods, and trends
- Leading and participating in PV development projects
- Deputizing the QPPV
Your qualifications
- Relevant educational degree within life science, e.g. pharmaceutical scientist, human biologist, or MD
- Excellent theoretical and proven practical understanding of PV: minimum of 5 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
- Excellent knowledge of safety database systems e.g., data collection systems, and other IT systems including Microsoft Office applications
- Strong analytical skills
- Possess strong written and verbal communication skills
- Fluency in spoken as well as written English
Moreover, you have the following personal skills:
- Ability to work independently as well as collaboratively with other team members and stakeholders
- Open-minded and open towards others’ opinions
- Have an innovative, proactive, result- and goal-oriented mindset
- Excellent negotiation and relation building skills
The department/team
The QPPV Office team is comprised of 7 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 +35 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 our 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 Klaus Bitsch-Jensen, Head of QPPV Office & EU-QPPV @ +45 41 95 90 30.
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 18.8.2022, 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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