Senior Professional/ Local Pharmacovigilance Relations/ Global Safety Standards and Compliance

Are you passionate about efficient global pharmacovigilance (PV) systems? Have you experience in quality management, implementation and maintenance of harmonized global PV systems in the affiliates? 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.

The job

In this position you will get an opportunity to influence the strategy for and implementation of one harmonized global PV system across LEO Pharma headquarters, affiliates and vendors. You will facilitate the communication and collaboration between LEO Pharma Global Safety (GS) and the local/regional PV staff, and also be responsible for part of the PV quality system related to the global PV system.

Manage contracts with the affiliates and maintain contact lists

• Maintain the pharmacovigilance contracts with the affiliates
• Maintain contact lists, e.g., to be included in the Pharmacovigilance System Master File

Building the bridge between global and local pharmacovigilance

• Be a point of contact for request related to the PV system from the affiliates and vendors working on behalf of LEO Pharma
• Work with other GS functions in supporting the local entities
• Organize and drive the regular meetings with the local PV staff

Local pharmacovigilance requirements

• Ensure that national ICSR reporting requirements and other local safety related requirements are implemented in LEOs global PV system
• Maintain GS systems for products, local pharmacovigilance requirements, and split of responsibilities between Affiliates/Area offices and LEO Pharma partners

PV Quality Documents

• Lead the implementation and maintenance of harmonized PV process across the local entities

Audits, Inspections and deviations

• In collaboration with the compliance team support PV audits, inspections, deviation- and CAPA management, when the local PV system is in scope

Compliance

• Set up KPIs and trending systems for local and reginal PV key activities
• Reporting of the compliance to Global Safety Leadership Team
• Continuously monitor and improve the system

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 28-Feb-2022 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 5,400 people worldwide. For more information, visit www.leo-pharma.com.