Drug Safety Advisor

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Are you a skilled professional with expertise in pharmacovigilance and a passion for ensuring global safety compliance? LEO Pharma is seeking a talented Drug Safety Advisor to join our Global Safety Surveillance (GSS) team. In this role, you will proactively manage the global safety profile of assigned clinical and marketed products, ensuring compliance with pharmacovigilance regulations and guidelines. If you have a strong medical/scientific background, excellent data analysis skills, and a commitment to patient safety, this is the opportunity for you

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.

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

Your Qualifications

1. 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.
2. Strong medical/scientific knowledge and evaluation skills, including signal evaluation and trending.
3. Strong understanding of global regulatory requirements (EMA/FDA/ICH).
4. Excellent data analysis and interpretation skills.
5. Proficiency in medical and scientific writing.
6. Familiarity with clinical/drug development processes and functions.
7. Fluent verbal and written English.
8. Strategic thinking, influencing, and collaboration skills.
9. Proficiency in Microsoft Office and internet communication and search facilities.

Your New Team

You will join Global Safety Surveillance which consists of 3 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.

Contact and Application

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Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.