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- Tasks: Lead safety surveillance and risk management for clinical development at MoonLake Immunotherapeutics.
- Company: MoonLake is an innovative biotech company transforming global healthcare.
- Benefits: Enjoy remote work options, a supportive learning environment, and clear career progression.
- Why this job: Join a dynamic team making impactful contributions to groundbreaking healthcare projects.
- Qualifications: Qualified Physician with 2-3 years in clinical safety and pharmacovigilance required.
- Other info: Work 2 days a week in our brand new Cambridge office.
The predicted salary is between 72000 - 108000 ÂŁ per year.
Director Pharmacovigilance & Drug Safety
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Director Pharmacovigilance & Drug Safety
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Join to apply for the Director Pharmacovigilance & Drug Safety role at MoonLake Immunotherapeutics (NASDAQ: MLTX)
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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.
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research
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Director Pharmacovigilance & Drug Safety employer: MoonLake Immunotherapeutics (NASDAQ: MLTX)
Contact Detail:
MoonLake Immunotherapeutics (NASDAQ: MLTX) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Pharmacovigilance & Drug Safety
✨Tip Number 1
Network with professionals in the pharmacovigilance and drug safety field. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends. This can help you gain insights into what MoonLake Immunotherapeutics values in candidates.
✨Tip Number 2
Familiarise yourself with MoonLake's products and their safety profiles. Understanding the specific therapeutic areas they focus on, such as dermatology or immunology, will allow you to speak knowledgeably during interviews and demonstrate your genuine interest in the role.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios in pharmacovigilance. Think about how you would handle safety data presentation or regulatory interactions, as these are key aspects of the role. Practising your responses can boost your confidence.
✨Tip Number 4
Showcase your project management skills by discussing past experiences where you successfully led safety initiatives or collaborated with cross-functional teams. Highlighting these competencies will align well with the expectations for a Director position at MoonLake.
We think you need these skills to ace Director Pharmacovigilance & Drug Safety
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance and drug safety. Emphasise your clinical practice background, particularly any roles related to safety data presentation and regulatory submissions.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Discuss your understanding of the safety profile of products and how your expertise aligns with the key accountabilities listed in the job description.
Highlight Relevant Skills: Clearly outline your project management and time management skills, as well as your ability to evaluate and present complex clinical data. Mention any specific experiences that demonstrate your knowledge of international pharmacovigilance requirements.
Prepare for Potential Questions: Anticipate questions related to your experience with regulatory authority interactions and safety reporting. Be ready to discuss specific examples from your past roles that showcase your expertise in these areas.
How to prepare for a job interview at MoonLake Immunotherapeutics (NASDAQ: MLTX)
✨Understand the Safety Profile
Make sure you have a deep understanding of the safety profile of the products you'll be discussing. Familiarise yourself with the disease under study, competitor safety profiles, and the mechanism of action. This knowledge will help you answer questions confidently and demonstrate your expertise.
✨Prepare for Regulatory Questions
Given the role's focus on regulatory interactions, be ready to discuss your experience with regulatory authorities. Brush up on international pharmacovigilance requirements, especially in the UK, Europe, and the US, as well as any past experiences you've had with audits or inspections.
✨Showcase Your Clinical Experience
Highlight your foundational training and experience in clinical practice, particularly in clinical safety and pharmacovigilance. Be prepared to discuss specific examples from your past roles, especially those related to phase III trial activities and safety data presentations.
✨Demonstrate Team Collaboration Skills
This position requires working within multi-disciplinary teams. Prepare examples that showcase your ability to collaborate effectively with peers and external experts. Emphasise your communication skills and how you've contributed to team success in previous roles.
