(Senior) Professional/ Pharmacovigilance Contract Specialist/ Global Safety Standards and Compliance

Are you passionate about efficient global pharmacovigilance (PV) systems? Have you experience in managing PV contracts? 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 (Senior) PV Contract Specialist position you will negotiate and manage PV contracts and become a subject matter expert (SME) for the area. You will work closely together with experienced colleagues, so if you are not advanced in the discipline, training can take place.

PV Contract Management

Handling of PV Agreements (PVAs)

• Manages, negotiates, and maintains PVAs with various LEO Pharma partners
• Manages and builds day-to-day relationship with partners and internal LEO Pharma stakeholders

PV contract SME

• Act as PV contract management SME
• Provide oversight (e.g., PSMF contribution, PV contract status meetings, ad hoc requests)
• Participates in audits and inspections, where PV contract management is in scope
• Supervises relevant personnel in PV contract management related topics

PV contract management data and documentation

• Storage of data and records in the contract management repository
• Maintains PV contract metadata

Management of LEO Pharma PV overview tools

• Responsibility and tasks related to systems for capturing responsibility split, reporting requirements and product responsibility overview

Collaboration with stakeholders

• Collaborates with external partners and relevant internal LEO stakeholders including LEO Pharma Global Safety, Affiliates, Global Legal, Commercial, 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
• 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

• Identify 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

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

You will be working in an international and cross-disciplinary environment, and you can look forward to becoming part of a dedicated team and a great work 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 09-April-2022.

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.