Compliance Manager, Global Pharmacovigilance & Clinical Development (GPCD)
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Hørsholm
ALK is on an ambitious journey to become the preferred allergy company globally and this is why we are looking for a new colleague to join us.
The position
In a constantly evolving regulatory framework ALK is seeking an ambitious and dedicated person to fulfill this support role to maintain a high level of compliance with internal and external regulatory requirements with the main focus on Pharmacovigilance.
You will be responsible for a wide range of tasks such as maintenance/support and update of our Standard Operating Procedures (SOPs) including deviations to these, Regulatory requirements review and Impact assessments, supporting regulatory inspections and internal audits, training and distribution of our Quality Documents, advice on regulatory guidelines, trending of quality parameters and reporting of these to GPCD Management.
Fields of responsibility
Your qualifications
The department/team
Our GPCD Compliance department consists of 3 passionate colleagues and you. We are striving to continuously support and improve our QMS. We always try to develop our competences and processes in order to meet the needs of the patients and all stakeholders, internally as well as externally. 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.
Apart from our stakeholders the Compliance team work closely together with our Quality Assurance departments to ensure regulatory compliance.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
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 no later than 15-Sep-2020.
Contact
For further information on the position please contact Sanne Mathias, Head of Compliance, GPCD (+45 41 95 90 59).
The position
In a constantly evolving regulatory framework ALK is seeking an ambitious and dedicated person to fulfill this support role to maintain a high level of compliance with internal and external regulatory requirements with the main focus on Pharmacovigilance.
You will be responsible for a wide range of tasks such as maintenance/support and update of our Standard Operating Procedures (SOPs) including deviations to these, Regulatory requirements review and Impact assessments, supporting regulatory inspections and internal audits, training and distribution of our Quality Documents, advice on regulatory guidelines, trending of quality parameters and reporting of these to GPCD Management.
Fields of responsibility
- Act as main compliance support to our Global Pharmacovigilance Department and a close collaboration with the Qualified Person for Pharmacovigilance (QPPV) Office.
- Provide relevant regulatory advice and support.
- Support GPCD with maintenance and continuous improvement of the Quality Management System (QMS).
- Act as project manager on relevant updates to the QMS and where relevant writing Quality Documents.
- Handle and process of deviations from GPCD processes on a daily basis including escalation of trends.
- Ensure that relevant Quality Documents are distributed to relevant staff via our electronic training module.
- Support ALK and GPCD in internal audits, Health Authority inspections, and Notified Body audits.
- Participate in cross-functional and/or function-area projects e.g. to implement new legislation/guidelines or other cross-functional tasks/projects.
- Support oversight of the GPCD quality system, including coordination of and input to Quality Management Review and Quality Activity Plans.
- Ad hoc project management within compliance
Your qualifications
- B.Sc. within nature science or similar
- 4-5 years of experience within Pharmacovigilance regulated areas including regulatory requirements regarding marketed products and clinical trials
- A team player with good analytical skills and quality-oriented mindset.
- Ability to understand various stakeholder needs whilst maintaining objectivity.
The department/team
Our GPCD Compliance department consists of 3 passionate colleagues and you. We are striving to continuously support and improve our QMS. We always try to develop our competences and processes in order to meet the needs of the patients and all stakeholders, internally as well as externally. 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.
Apart from our stakeholders the Compliance team work closely together with our Quality Assurance departments to ensure regulatory compliance.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
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 no later than 15-Sep-2020.
Contact
For further information on the position please contact Sanne Mathias, Head of Compliance, GPCD (+45 41 95 90 59).
Information og data
Denne ledige stilling har jobtypen "Finansmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 10.6.2020, 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.
- Finansmedarbejder
- Hørsholm
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