Senior Drug Safety Advisor Jobs
Senior Drug Safety Advisor Jobs At LEO Pharma, They help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. You will join Global Safety Surveillance which consists of 2 teams both working with products in all phases of the drug life cycle and striving to safeguard our patients. We are an ambitious team 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.
Job Position: Senior Drug Safety Advisor
Field of work: Clinical Development
Job ID: 1522
Location: Gdańsk 80-309, Poland
Contract type: Permanent
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 overall objective will be to ensure continuous safety surveillance of marketed compounds/products.
Your main tasks will be to:
- Provide overall safety surveillance for assigned products, on an on-going basis
- Conduct medical evaluation/review of Adverse Events reports, Summary of Product Characteristics, Company Core Safety Information, patient information leaflets and other safety information
- Write and review aggregated safety reports, Risk Management Plans, safety sections required in documents such as CCSI/core SmPC and other relevant safety reports
- Conduct signal detection and management
- Prepare PV specific documents for regulatory submissions
- Ensure correct medical evaluation of safety information (e.g. adverse events) from all LEO products
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 4-year experience working in a project oriented, international organization preferably in pharmacovigilance
- Strong medical/scientific knowledge/evaluation knowledge
- Solid knowledge of global (EMA/FDA/ICH) regulatory requirements
- Strong data analysis and interpretation skills
- Medical and scientific writing skills
- Fluent verbal and written English
- Strategic thinking, influencing, and collaboration