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Senior Drug Safety Advisor

3 miesięcy temu

Gdańsk, Polska LEO Pharma Pełny etat
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.
 

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