EDUCATION

Qualified healthcare professional or Life Sciences graduate. Advanced degree in a biologic/medical/clinical/nursing field, such as Pharmacist/PharmD or PhD in a topic relevant to the position is beneficial.

EXPERIENCE

• Five or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g., global CRO), including at least 3 years in clinical drug safety and risk management.
• Prior experience in pharmacovigilance with advanced knowledge of PV regulation and cross-functional collaboration.
• Significant exposure to PV audits/regulatory inspections and demonstrated Root Cause Analysis and CAPA development skills.
• Expertise in preparing clinical safety assessments and regulatory reports/submissions involving safety data.
• Experience managing vendor relationships and overseeing outsourced safety activities.
• Experience with safety (or other) issue management.
• Therapeutic area expertise in dermatology, rheumatology, immunology, or GI is an advantage.
• Proven operational understanding of GCP/GVP.

SKILLS / KNOWLEDGE / BEHAVIOURAL COMPETENCIES

• Familiarity with PV processes such as case processing, signal detection, aggregate safety reporting, and clinical study safety management.
• Strong knowledge of international pharmacovigilance requirements, particularly within the UK, EU, and US, including experience interacting with regulatory bodies.
• Demonstrates independent and high-level conduct of safety science responsibilities.
• Proactively assumes responsibility for complex deliverables.
• Strong process improvement mindset and ability to work collaboratively across functions.
• Effective presentation skills; able to summarize and articulate key safety considerations and decisions.
• Ability to train others in departmental procedures and best practices.

WHY US?

WHY US?An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

ABOUT US

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com

This hybrid role is responsible for managing drug safety vendor oversight and safety operational activities, as well as contributing to safety surveillance for MoonLake products in clinical development. The individual will collaborate cross-functionally and work with external safety teams, ensuring adherence to global pharmacovigilance & GCP regulations, and ensuring inspection readiness.