Drug Safety Advisor
3 miesięcy temu
Your overall objective will be to ensure continuous safety surveillance of marketed products. Your main tasks 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
• 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
• Preferable 1-5 years of relevant experience (working in a project oriented, international organization within PV, regulatory affairs, or drug development)
• Basic medical/scientific knowledge/evaluation knowledge
• Strong data analysis and interpretation skills
• Quality-oriented mindset
• Strong 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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