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- Tasks: Lead safety surveillance and risk management for innovative clinical development programmes.
- Company: Join MoonLake, a dynamic biotech company transforming global healthcare.
- Benefits: Flexible remote work, career growth opportunities, and a supportive learning environment.
- Why this job: Make a real impact on groundbreaking projects in inflammatory disease treatment.
- Qualifications: Qualified Physician with experience in clinical safety and pharmacovigilance.
- Other info: Collaborate with experts and contribute to revolutionary healthcare solutions.
The predicted salary is between 48000 - 72000 £ per year.
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:
- Developing and maintaining an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g. disease under study, safety profile of competitors, mechanism of action).
- Safety lead for safety surveillance activities, and accountable for the ongoing signal detection, evaluation, and periodic review of emerging safety data (e.g. AEs, SAEs, Labs), assess for safety trends, and timely presentation of important/urgent safety issues together with risk communication/management strategy to the Drug Safety Committee (DSC), company senior management and external stakeholders (e.g. Independent Data Safety Monitoring Boards).
- Provide medical evaluation of Individual Case Safety Reports (ICSRs) alongside the study Medical Director/Clinical Science Specialist for assigned products.
- Contribute to the planned BLA/MAA activities and act as subject matter expert for safety related content.
- In collaboration with internal stakeholders and external vendors, direct the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR) investigator communications as necessary.
- Respond to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities and advisory committees.
- Lead and contribute to the development of the Risk Management Plan.
- Act as the safety representative on cross-functional development teams including study teams.
- Provide safety related training to company employees as is required.
Your profile
Education: Qualified Physician (GMC or GMC permissible).
Experience: Foundational training and experience in clinical practice with a general medicine background. Solid experience (a minimum of 2-3 years) in clinical safety and pharmacovigilance and specifically in phase III trial activity. Expertise in preparing clinical safety assessments and regulatory reports/submissions involving safety information. Demonstratable and direct experience of safety data presentation in Marketing authorization and Biologics license applications. Prior therapeutic experience in dermatology, rheumatology, immunology or GI would be an advantage.
Skills/knowledge/behavioural competencies: Possessing a strong knowledge of international pharmacovigilance requirements, specifically in the UK, Europe and US and prior experience of regulatory authority interactions. Good project management and time management skills required. Strong knowledge of global regulatory requirements for safety reporting and labeling. Demonstrated ability to independently evaluate, interpret and present complex clinical data. Demonstrated ability to work within a multi-disciplinary team of peers and outside experts. Good organizational and planning talent with excellent communication skills (written or spoken).
Work Location: 2 days a week in our brand new Cambridge office.
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.
What we offer:
- Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
- Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
- Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
- Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
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 **** and is headquartered in Zug, with hubs in Cambridge and Porto.
Director Pharmacovigilance in Cambourne employer: MoonLake Immunotherapeutics
Contact Detail:
MoonLake Immunotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Pharmacovigilance in Cambourne
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. A personal connection can often lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of safety surveillance and risk management. Be ready to discuss your experience with clinical safety assessments and how you’ve handled safety data in the past.
✨Tip Number 3
Showcase your expertise! Bring examples of your work, like regulatory reports or safety presentations, to the interview. This will demonstrate your hands-on experience and understanding of the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our innovative team at MoonLake.
We think you need these skills to ace Director Pharmacovigilance in Cambourne
Some tips for your application 🫡
Know Your Stuff: Before you start writing, make sure you understand the role inside out. Dive into the job description and highlight key responsibilities and qualifications. This will help us see how your experience aligns with what we're looking for.
Tailor Your Application: Don’t just send a generic CV and cover letter! Tailor your application to reflect the specific skills and experiences that match the Director Pharmacovigilance role. Use keywords from the job description to show us you’re a perfect fit.
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just listing duties. Use numbers and examples to illustrate how you've made an impact in previous roles, especially in clinical safety and pharmacovigilance.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re genuinely interested in joining our team!
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Know Your Stuff
Make sure you have a solid grasp of pharmacovigilance principles and the specific safety profiles of the products you'll be discussing. Brush up on recent developments in the field, especially related to dermatology, rheumatology, and immunology, as these areas are particularly relevant for this role.
✨Showcase Your Experience
Prepare to discuss your previous experience in clinical safety and pharmacovigilance, especially during phase III trials. Be ready to share specific examples of how you've handled safety data presentations and regulatory submissions, as this will demonstrate your expertise and readiness for the role.
✨Understand the Company’s Vision
Familiarise yourself with MoonLake's mission and the innovative work they're doing in inflammatory diseases. This will not only help you align your answers with their goals but also show your genuine interest in contributing to their impactful projects.
✨Prepare for Regulatory Questions
Since the role involves responding to safety questions from regulatory authorities, think about potential scenarios or questions that might arise. Prepare concise, clear responses that reflect your understanding of global regulatory requirements and your ability to communicate complex data effectively.
