YOUR QUALIFICATIONS

• University degree in health or biological science (MD, MSc, MSc Pharm, or equivalent) with a minimum of 2 years of experience in a project-oriented, international organization
• Strong medical/scientific knowledge and evaluation skills, including signal evaluation and trending.
• Strong understanding of global regulatory requirements (EMA/FDA/ICH).
• Excellent data analysis and interpretation skills.
• Proficiency in medical and scientific writing.
• Familiarity with clinical/drug development processes and functions.
• Fluent verbal and written English.
• Strategic thinking, influencing, and collaboration skills.
• Proficiency in Microsoft Office and internet communication and search facilities.

YOUR ROLE

As a Drug Safety Advisor, your objective will be to proactively manage the global safety profile (surveillance program) for assigned clinical and marketed products, ensuring compliance with pharmacovigilance regulations and guidelines.

• Provide overall safety surveillance for assigned products on an ongoing basis.
• Ensure updates of Serious Adverse Events (SAEs) from clinical trials are accurately recorded in the LEO safety database.
• Review and contribute to clinical trial reports, clinical submission documents, and labeling documents.
• Prepare pharmacovigilance-specific documents for regulatory submissions.
• Conduct medical evaluation/review of adverse event reports, Summary of Product Characteristics (SmPCs), patient information leaflets, and other safety information.
• Write and review aggregated safety reports, Risk Management Plans (RMPs), and safety sections required in various documents.
• Perform case evaluation for all LEO cases, with a focus on unlisted and serious cases.
• Ensure correct medical evaluation of safety information from all LEO products.