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- Tasks: Lead safety surveillance and risk management for innovative clinical development programmes.
- Company: Join MoonLake, a dynamic biotech company pushing healthcare boundaries.
- Benefits: Flexible remote work, career growth opportunities, and a supportive learning environment.
- Why this job: Make a real impact on global healthcare with groundbreaking projects.
- Qualifications: Qualified Physician with experience in clinical safety and pharmacovigilance.
- Other info: Work 2 days a week in our brand new Cambridge office.
The predicted salary is between 43200 - 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.
Contact Detail:
MoonLake Immunotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Pharmacovigilance & Drug Safety
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance and drug safety field on LinkedIn. Join relevant groups, attend webinars, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of safety surveillance and risk management. Familiarise yourself with recent trends and case studies in the industry. We want you to walk in feeling confident and ready to impress with your expertise!
✨Tip Number 3
Showcase your passion for the role! When you get the chance to speak with potential employers, let them know why you’re excited about pharmacovigilance and how you can contribute to their mission. We love seeing candidates who are genuinely enthusiastic about making an impact.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’ve got some great resources to help you along the way. Let’s get you that dream job together!
We think you need these skills to ace Director Pharmacovigilance & Drug Safety
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in pharmacovigilance and drug safety. We want to see how your background aligns with the key accountabilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're passionate about this role and how your skills make you the perfect fit. Don’t just repeat your CV; use this space to showcase your personality and enthusiasm for the position.
Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles that relate directly to safety surveillance and risk management. We love seeing concrete examples of your work in clinical safety and regulatory submissions.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Know Your Stuff
Make sure you have a solid grasp of the safety profile of the products you'll be discussing. Familiarise yourself with the disease under study, competitor safety profiles, and mechanisms of action. This knowledge will not only impress your interviewers but also show that you're genuinely interested in the role.
✨Showcase Your Experience
Be ready to talk about your previous experience in clinical safety and pharmacovigilance. Highlight specific examples from your past roles, especially any involvement in phase III trials or regulatory submissions. This will demonstrate your expertise and how it aligns with what they’re looking for.
✨Prepare for Technical Questions
Expect questions about safety data evaluation, signal detection, and risk management strategies. Brush up on international pharmacovigilance requirements and be prepared to discuss how you've handled safety issues in the past. This will show that you can think critically and act decisively in high-pressure situations.
✨Communicate Clearly
Since excellent communication skills are key for this role, practice articulating complex clinical data in a straightforward manner. Whether it's written or spoken, being able to convey your thoughts clearly will set you apart. Consider doing mock interviews to refine your delivery.
