Director Pharmacovigilance & Drug Safety

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Director Pharmacovigilance & Drug Safety, Cambridge

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Client:

MoonLake Immunotherapeutics

Location:

Cambridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

664ab493b783

Job Views:

23

Posted:

13.06.2025

Expiry Date:

28.07.2025

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Job Description: Job Purpose

The Director Pharmacovigilance & Drug Safety serves as the Pharmacovigilance/Drug Safety Lead for safety surveillance & risk management activities for MoonLake's clinical development programs.

Key Accountabilities:

• Develop and maintain an understanding of the safety profile of assigned products and the relevant strategic context.
• Lead safety surveillance activities, including signal detection, evaluation, and review of safety data, and communicate safety issues to relevant committees and stakeholders.
• Provide medical evaluation of Individual Case Safety Reports (ICSRs) alongside study Medical Directors.
• Contribute to BLA/MAA activities and serve as a safety content expert.
• Coordinate the development and compliance of safety reports and investigator communications.
• Respond to safety questions from regulatory authorities and manage audits and inspections.
• Lead safety sections of regulatory documents and prepare for meetings with authorities.
• Develop and lead Risk Management Plans.
• Represent safety in cross-functional teams and provide safety training as needed.

Your profile

Education:

• Qualified Physician (GMC or equivalent).

Experience:

• Clinical practice with a general medicine background.
• At least 2-3 years in clinical safety and pharmacovigilance, especially in phase III trials.
• Experience in safety assessments and regulatory reporting.
• Experience with safety data presentation for regulatory submissions.
• Therapeutic experience in dermatology, rheumatology, immunology, or GI is advantageous.

Skills/Knowledge/Behavioral Competencies:

• Strong knowledge of international pharmacovigilance requirements and regulatory interactions.
• Good project and time management skills.
• Ability to interpret complex clinical data and work within multidisciplinary teams.
• Excellent organizational and communication skills.

Work Location:

• 2 days a week in our Cambridge office.

Why us?

An exciting job opportunity awaits you! MoonLake is a dynamic and innovative biotech company. We offer a learning environment, impactful work, flexible working options, and clear career progression.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on inflammatory diseases. Founded in 2021, headquartered in Zug, with hubs in Cambridge & Porto. More info at