Senior Drug Safety Advisor

Field of work:  Clinical Development
Posting Date:  14 May 2024

Application deadline:  
Location: Gdansk 80-309, , Poland 
Contract type: Permanent 
Job ID: 2047 

 

image.email.leo-pharma.com

 

 

Role Description

Are you ready to take your career to the next level and develop in a role that will allow you to manage the global safety profile for post marketed products?

LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you. 
 
Your role

 

Your overall objective will be to ensure continuous safety surveillance of marketed products as the Safety Lead for a product portfolio. 
As the Safety Lead you should be able to have a high-level overview of upcoming activities for products within your portfolio and provide strategic safety input to the rest of the organization in cross-functional teams.
 
Your main tasks – together with a team of other Drug Safety Advisors – will be to:

 

•    Provide overall safety surveillance for assigned products, on an on-going basis
•    Perform medical evaluation and causality assessment of reported adverse events from all LEO products
•    Conduct signal detection and management
•    Write and review aggregated safety reports (e.g. PSURs), risk management plans, safety sections required in documents such as Company Core Safety Information and other relevant safety reports
•    Lead Safety Management Team(s) and be a Subject Matter Expert for certain pharmacovigilance (PV) activities
•    Prepare PV specific documents for regulatory submissions

 

 

Your qualifications 

 

To succeed in this role, we imagine that you have the following qualifications:
 
•    University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent 
•    At least 5 years of relevant experience working in a project oriented, international organization and preferably 3 years of safety surveillance experience
•    Solid medical/scientific knowledge/evaluation knowledge
•    Strong data analysis and interpretation skills
•    High quality mindset
•    Strategic thinking, influencing, and collaboration
•    Team player skills with a collaborative attitude and good communication skills
•    Fluent verbal and written English

 
Your new team

 

You will join the Global Safety Surveillance hub in Gdansk. We work flexible at LEO Pharma meaning you can work 3-5 days/week from the office and 2 days from home. There is also the opportunity to work remote, and travel to the office for a couple of days per month.
 
We are an ambitious department driven by a high level of integrity, science, and passion for our work. We value a great collaborative atmosphere where you can always reach out to a colleague or manager for support and sparring.
 
Contact and application

 

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

 

Beyond the skin


At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.


At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.


For certain positions, LEO Pharma might complete a background check conducted by a third party.