Principal Safety Advisor for Global Safety Surveillance

Do you want to work with drug safety in clinical development?

As Senior Safety Advisor you will be a key player in the safety surveillance and development of one of LEO Pharma’s new biologics Tralokinumab for the treatment of atopic dermatitis. You will become part of a team of 6 Safety Advisors working with an investigational, fully human monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis. The product specifically blocks the effects of the cytokine IL-13, which plays an important role in the pathophysiology of atopic dermatitis – one of the most common chronic, inflammatory skin diseases.

LEO Pharma’s ambitions

LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have recently introduced our 2025 strategy, which aims to accelerate our efforts in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma is rapidly changing from primarily focusing on topical treatments, to being at the forefront of scientific advancements to help patients.

Job description

We are offering a job with considerable individual responsibility, challenges, and the opportunity to develop your professional and personal competencies. As Principle Safety Advisor, your focus is to be globally responsible for effective safety risk management processes with main tasks including but not limited to:

Leading safety management teams

Assisting with establishing and developing consistent safety risk management practices across projects, processes and documents

Signal detection and management

Participation in clinical trial teams providing safety input to clinical development discussions and documents, e.g. trial protocols and Investigator’s Brochure

Preparation of safety input to various regulatory documents

Preparation of DSURs and Periodic line listings to the authorities

Medical assessment of SAEs/SUSARs

Qualifications

University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent)

5+ years of experience from the pharmaceutical industry in pharmacovigilance/drug safety departments and/or medical/clinical development

A solid understanding of medical concepts, disease processes, scientific methodology, drug development and data analysis is very important, documented scientific training (e.g. PhD) and experience from interactions with regulatory authorities will be an additional advantage

A proactive and open-minded approach

Since the job involves multiple tasks with fixed deadlines ongoing at the same time, the ability to focus, stay calm and work independently as well as in teams, is a necessity

Strong collaboration skills and experience from working in cross functional teams

An analytical mindset and an eye for detail

Good and strong written and verbal English skills

We are a dedicated and ambitious team

Global Safety Surveillance consists of 30+ dynamic colleagues striving to safeguard our patients and to improve the quality of our processes and developing our competencies to meet the need of the patients and other stakeholders, internally as well as externally. We are driven by a high level of integrity, science, passion for our work and an open-minded approach.

The position is placed in the LEO Pharma headquarters in Ballerup.

For more information

Please contact Head of Global Safety Surveillance Innovative, Søren Lindberg at +45 31233919.