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Director Pharmacovigilance & Drug Safety, Cambridge col-narrow-left
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
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