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Are you passionate about efficient global pharmacovigilance (PV) systems? Have you experience in managing either PV audits & inspections or PV contract? 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 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.
In this new position you will manage and coordinate Global Safety (GS) activities in relation to the planning, conduct and follow-up on PV audits and inspections, including the CAPA management. In addition, you will handle PV Contract Management related tasks and contribute to the ongoing development of PV Contract Management activities and processes to secure continuous compliance with applicable PV regulation. You will work closely together with experienced colleagues, so if you are not advanced in both disciplines, training can take place.
PV audit and inspection
In collaboration with Global QA coordinates and prepare for internal audits and external Health Authority inspections - for GS, affiliates and partners
Supports GS during internal audits (part of back office and auditee)
Oversees and follow-up on performance of audit and inspection CAPA management within GS
Implements, documents, and analyses the PV audit process and CAPA Management and to translate into new or improved PV processes
PV Contract Management
Handling of PV Agreements (PVAs)
Manages, negotiates, and maintains PVAs with various LEO Pharma partners to ensure, that the PVAs which LEO Pharma has entered with 3rd parties are in line with current and effective PV regulatory requirements and LEO Pharma's procedures and standards
Manages and builds day-to-day relationship with partners and internal LEO Pharma stakeholders.
Handling of PV contract management
Assumes the role as PV contract management subject matter expert and a key contributor with knowledge and support as needed
Proactively contributes to QPPV oversight by means of relevant measures (e.g. PSMF contributions, PV contract management status meetings, ad hoc requests)
Participates in audits and inspections for which PV contract management is within scope
Supervises relevant personnel in PV contract management related topics
PV contract management data and documentation
Ensures storage of current, correct, and complete data and records in the contract management repository
Maintains PV contract associated metadata and provide further input to how to ensure continuous improvement of data quality
Management of LEO Pharma PV overview tools
Assumes administrator role for regulatory reporting requirements as described in LEO Pharma GS QMS documents for own agreements
Maintains and updates data covering products, local PV requirements, and split of responsibilities between Affiliates/Area offices and LEO Pharma partners in the systems
Collaboration with stakeholders
Proactively collaborates with external partners relevant internal LEO stakeholders including LEO Pharma GS, Affiliates/Area Offices, Global Legal, Commercial Regions and Business Development, Global QA, Global Regulatory Affairs, Global Procurement, R&D Vendor Management, IT and other business units in relation to relevant aspects of PV contract management in order to support the goals of LEO Pharma and Global Safety
Creates awareness of the requirements and the significance of PV agreements and influences relevant stakeholders in and outside the LEO Pharma Organisation to create results
PV Contract Management development activities
Proactively seek to challenge to identify and improvement areas within PV contract management and implement lean and effective solutions
Networks within own area of expertise to seek opportunities for development activities
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
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.Please apply via the link at our website and remember to attach application and CV. Send your application to us as soon as possible and no later than 18. March 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.