Principal Professional /Global Safety Standards and Compliance/QPPV Officer
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Ballerup
Are you experienced within pharmacovigilance (PV) and have a deep understanding of the PV regulations? Are you able analyzing complex situations and skilled in leading PV compliance and improvement activities?
LEO Pharma is looking for a QPPV Officer, who can provide senior support to the organization and work closely together with the QPPV and the deputy QPPV. In addition, act as the owner of the PV Intelligence Process and act as the Data Protection Focal Point at Global Safety (GS)!
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. If you have experience in quality management, implementation and maintenance of global PV systems in the affiliates, then you may be our new colleague. In Global Safety Standards and Compliance, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
In this position you will act on behalf of the QPPV for delegated tasks. You will be primary responsible for all tasks related to assigned products, projects and other tasks. In addition, you will be the process owner of the PV intelligence process at LEO Pharma and the Data Protection Focal Point at GS.
Act on behalf of QPPV for delegated tasks
In daily work, the QPPV, the deputy QPPV and the QPPV Officer will partner and share the work. The QPPV Officer is primary responsible for all tasks related to the assigned products and tasks.
PV Intelligence
- Lead the regulatory surveillance
- Inform the GS Leadership Team about new external standards for implementation
- Provide an overview of identified external standards and support the relevant subject matter experts in documentation of their gap analyses
- Ensure ongoing development and maintenance of the QMS document, which describe the PV Regulatory Intelligence process.
- Make gap analysis and implementation plans as agreed for selected new external standards.
- Review selected GS QMS documents
- External presentation i.e. advocacy for LEO opinions on regulatory requirements
- Participate in external benchmark groups
Data Protection Focal Point
- Facilitate that the global governance framework is reflected in LEO Pharma local guidance’s and instructions.
- Maintain relevant registers / documentation to demonstrate compliance to personal data regulation
- Support line management in achieving personal data compliance, e.g. by:
- Facilitating that employees are adequately trained.
- Informing about GDPR requirements for documentation and retention.
- Handling subject access requests and objections.
- Assist as need for status reporting to Corporate and Pharma Legal.
- Handling personal data breaches.
- Supporting the Data Protection Officer in the dialogue with local authorities
- Review Data Protection Impact Assessments and assist upon request. - Support role to line management in maintains of Personal Data Maps
- Support affiliates with regards to compliance with global PV related data privacy requirements
- Provide PV and data privacy expert advices to college in LEO as needed
- Support to the organization
- Ad hoc support to the global PV organization
- Lead and support improvement and compliance initiatives
Your qualifications
- Pharmacist or a degree in health sciences
- Substantial experience within the pharmaceutical industry
- Deep understanding of global regulatory PV legislation and guidance
- Ability to analyze complex situations and improve or change processes
- Is a go-to person, who can guide and train other professionals in PV
- Participate in defining the strategy for PV
- Lead key PV compliance and improvement activities
- Excellent communication skills, influencing skills and demonstrated credibility when partnering with senior corporate levels; ability to present strategies, policy & work processes
- Capability to take a Global Perspective and to challenge status quo & lead change
- Capability to push boundaries to execute fresh quality & compliance methods & systems
- Strong analytic skills and ability to make sound judgments balancing business, financial & compliance requirements;
- Strong relationship builder - ability to work with PV partners across global boundaries e.g. Affiliates
- Good IT skills and experienced user of common Microsoft Office programs
- Good written and oral English skills
Your new team
This is an interesting job with great opportunities for both personal and professional development. You will be working in an international and cross-disciplinary environment, and you can look forward to becoming part of a dedicated team, who uphold a great working environment.
You will be located in Ballerup, and report into the EU QPPV, Head of Global Safety Standards and Compliance.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Berit Nautrup Andersen, Director QPPV, at + 45 5379 8853.
. Send your application to us as soon as possible, and no later than 31 Mar 2021 as we will be conducting interviews on a continuous basis.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 11.3.2021, 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
- Ballerup
- Onsdag den 31. marts 2021
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