Director Pharmacovigilance & Drug Safety

MoonLake Immunotherapeutics; Cambridge; Hybrid; GBP 85,000 - 120,000; Full time

Job summary

MoonLake Immunotherapeutics is hiring a Director of Pharmacovigilance & Drug Safety in Cambridge. In this role, you will lead safety surveillance for clinical development programs, contribute to regulatory submissions, and ensure compliance with pharmacovigilance standards. This position offers hybrid working options and opportunities for impactful work in a dynamic biotech environment.

Benefits

Flexible working options

Career progression opportunities

Learning environment

Qualifications

• Qualified Physician with relevant licensing.
• Experience in clinical safety and pharmacovigilance for 2-3 years.
• Background in general medicine and clinical practice.

Responsibilities

• Lead safety surveillance activities including signal detection.
• Develop Risk Management Plans and regulatory documents.
• Provide medical evaluations of safety reports.

Skills

Strong knowledge of international pharmacovigilance requirements

Project and time management

Ability to interpret complex clinical data

Organizational and communication skills

Education

Qualified Physician (GMC or equivalent)

Job description

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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 www.moonlaketx.com