Senior Professional /Pharmacovigilance Compliance Specialist

Have you experience in managing PV audits & inspections? Are you passionate about efficient global pharmacovigilance Quality Management Systems? then you might be the new colleague we are looking for!

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. In LEO Pharma you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

In this senior PV Specialist position, you get to work with different aspects of the pharmacovigilance (PV) Quality Management System (QMS) together with a great team of dedicated and skilled PV professionals in Global Safety Standards and Compliance.

PV Audits, Inspections, and Deviations

• In collaboration with Global QA coordinate and prepare for internal audits and external Health Authority inspections – for GS, affiliates and partners
• Support GS during internal audits (part of back office and auditee)
• Oversee and follow-up on performance of audit and inspection CAPA management within GS
• Implement, document, and analyze the PV audit process and CAPA Management and to translate into new or improved PV processes
• Manage delegated deviation reports in MyQMS, including monitoring and follow-up with the responsible functional area to ensure timely closure of deviation reports.

PV Quality Management System (QMS) Documents

• Develop and manage the process for PV QMS Documents (i.e. Standard Operating Procedures, Work Instructions and Enclosures) in accordance with LEOs overall strategy
• Collaborate with authors to ensure that GS QMS Documents are adhering to the process and templates, and provide guidance and input, where relevant
• Maintain the oversight of QMS documents for the PSMF
• Contribute to the maintenance of GS SOP matrix

PSMF Management

• Develop and maintain a GS process the generation, oversight and archiving of regulatory documents requested for registrations and renewals (e.g. QPPV Guarantee Letters and PSMF documents)
• Develop and maintain oversight and review of local PSMFs
• Support the maintenance of the EU and UK PSMF, if required

Other GSSC tasks

• Daily surveillance of GSSC shared mailboxes
• Drive tasks of high complexity in internal or cross-functional projects, as delegated
• 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, Head of Global Safety Standards and Compliance, at + 45 5379 8853. . Send your application to us as soon as possible and no later than 18th. October 2021.

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 5,400 people worldwide. For more information, visit www.leo-pharma.com.