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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 Immunotherapeuticsis 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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