Senior Compliance Specialist, Global Safety Standards and Compliance
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Ballerup
Are you passionate about quality management and efficient global pharmacovigilance systems?
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 pharmacovigilance 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 manage and coordinate the global pharmacovigilance (PV) compliance system by compilation and management of compliance data and documents for Global Safety (GS). In addition, you will manage and coordinate PV audits, inspections and deviations from the PV QMS, including the CAPA management. You will also be the involved in the PV intelligence process supporting the review of regulatory changes and ensuring an oversight and implementation of the key PV requirements.
Compliance Monitoring and Tracking
Managing a global tracking system to provide tracking and monitoring of safety reporting of ICSRs and aggregated safety reports
GS Quality Management
Audits, Inspections and deviations
Local pharmacovigilance requirements
Other tasks
Your qualifications
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 18th of October 2020 as we’ll be conducting interviews on a continuous basis.
About LEO Pharma LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
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 pharmacovigilance 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 manage and coordinate the global pharmacovigilance (PV) compliance system by compilation and management of compliance data and documents for Global Safety (GS). In addition, you will manage and coordinate PV audits, inspections and deviations from the PV QMS, including the CAPA management. You will also be the involved in the PV intelligence process supporting the review of regulatory changes and ensuring an oversight and implementation of the key PV requirements.
Compliance Monitoring and Tracking
Managing a global tracking system to provide tracking and monitoring of safety reporting of ICSRs and aggregated safety reports
- Tracking and monitoring of PV KPI’s to enable analysis and calculation of the overall compliance performance, in order to meet PV regulatory obligations with timeframes
- Initiate corrective and preventive actions to avoid future non-compliances
- Assess, analyze and report the global PV compliance status and risks both within LEO Pharma and partners
- Flagging emerging issues or late reporting
- Developing and maintaining related GS QMS documents
- Contributing to QPPV oversight by providing updated lists to relevant PSMF annexes
GS Quality Management
- Handling and maintaining of the global PV Deviation system
- Handling and documentation of deviations, including quality assurance
- Overseeing PV deviations and reporting on related KPIs to QPPV and GS Management
- Guiding affiliates concerning deviation requirements and management o Managing and maintaining the periodic Quality Report to the QPPV and GS Management
Audits, Inspections and deviations
- Support to Global QA before, during and after PV audits
- Coordinating GS support before, during and after inspections
- Supporting the management of local deviation reports and related CAPAs
Local pharmacovigilance requirements
- Ensure that national ICSR reporting requirements or other local safety related requirements are implemented in the global PV system
- Maintain and update GS oversight of products, local PV requirements, and split of responsibilities between Affiliates/Area offices and LEO Pharma partners
Other tasks
- Daily surveillance of GS mailbox in relation to Global Safety Standards and Compliance
- Drive tasks of high complexity in internal or cross-functional projects
- Develop or improve procedures within area of responsibility
Your qualifications
- Pharmacist, other relevant Degree in Health Sciences or equivalent
- Extensive experience within the pharmaceutical industry
- Solid Pharmacovigilance knowledge
- Strong quality mindset
- Good communication skills
- Structured and detail oriented
- Able to set the direction and deliver results
- Independently make solve common issues and make improvements to systems within the area of responsibility
- Ability to guide and train other senior colleagues and managers
- Proficient in verbal and written English
- Good IT skills and experienced user of common Microsoft Office programs
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 18th of October 2020 as we’ll be conducting interviews on a continuous basis.
About LEO Pharma LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
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 2.10.2020, 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
- Ballerup
- Søndag den 18. oktober 2020
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