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For Companies At a Glance
- Tasks: Manage drug safety operations and vendor oversight while ensuring compliance with regulations.
- Company: Join MoonLake, a dynamic biotech company innovating in global healthcare.
- Benefits: Enjoy a hybrid work model, career growth opportunities, and a supportive learning environment.
- Why this job: Be part of impactful projects that transform healthcare and collaborate with experienced professionals.
- Qualifications: Qualified healthcare professional with 5+ years in clinical drug development and pharmacovigilance experience.
- Other info: Work two days a week at our Porto or Cambridge office.
The predicted salary is between 54000 - 84000 £ per year.
Job Purpose
This hybrid role is responsible for managing drug safety vendor oversight and safety operational activities, as well as contributing to safety surveillance for MoonLake products in clinical development. The individual will collaborate cross-functionally and work with external safety teams, ensuring adherence to global pharmacovigilance & GCP regulations, and ensuring inspection readiness.
Major Accountabilities
PV Operations & Vendor Oversight
- Setup/update Safety Management Plans (SMPs) & monitor safety vendor deliverables including ICSR and periodic report compliance.
- Maintain and monitor the quality of outsourced PV activities; ensure the activities are compliant with GVP, GCP and global regulatory requirements.
- Monitor KPI compliance of the vendor for the outsourced activities.
- In collaboration with safety vendor and internal/external Data Management groups, perform/oversee TMF filing/SAE reconciliation activities.
Inspections & Audits
- Serve as Point of Contact for internal as well as external teams (e.g., safety vendor) on matters of clinical safety/PV audits/inspections.
- Oversee the preparation and review of documents used in GVP/GCP activities; present GVP activities during regulatory inspections.
- In collaboration with internal & external stakeholders, participate in and lead development & management of drug safety related CAPAs.
- Perform gap analysis; develop and/or update safety-related SOPs, processes and practices and ensure appropriate documentation for inspection/audit readiness.
Safety Surveillance
- In collaboration with the Director of Drug Safety, participate in monitoring, review, analyses, interpretation and evaluation of incoming safety information (instream clinical study monitoring and aggregate safety data review); highlight potential safety signals.
- Contribute to the strategy and generation/review of safety assessments for signals or issues (including product quality); contribute to the development and maintenance of the development RMP.
- Lead the generation of aggregate safety reports (e.g., DSURs).
- Act as the safety representative in assigned clinical study teams, including providing safety input to study design, conduct, data analysis and interpretation.
- In partnership with the Director of Drug Safety, support presentation of important safety issues to the Drug Safety Committee (DSC) and other internal/external review and governance committees as needed.
Your profile
Education
Qualified healthcare professional or Life Sciences graduate. Advanced degree in a biologic/medical/clinical/nursing field, such as Pharmacist/PharmD or PhD in a topic relevant to the position is beneficial.
Experience
- Five or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g., global CRO), including at least 3 years in clinical drug safety and risk management.
- Prior experience in pharmacovigilance with advanced knowledge of PV regulation and cross-functional collaboration.
- Significant exposure to PV audits/regulatory inspections and demonstrated Root Cause Analysis and CAPA development skills.
- Expertise in preparing clinical safety assessments and regulatory reports/submissions involving safety data.
- Experience managing vendor relationships and overseeing outsourced safety activities.
- Experience with safety (or other) issue management.
- Therapeutic area expertise in dermatology, rheumatology, immunology, or GI is an advantage.
- Proven operational understanding of GCP/GVP.
Skills / Knowledge / Behavioural Competencies
- Familiarity with PV processes such as case processing, signal detection, aggregate safety reporting, and clinical study safety management.
- Strong knowledge of international pharmacovigilance requirements, particularly within the UK, EU, and US, including experience interacting with regulatory bodies.
- Demonstrates independent and high-level conduct of safety science responsibilities.
- Proactively assumes responsibility for complex deliverables.
- Strong process improvement mindset and ability to work collaboratively across functions.
- Effective presentation skills; able to summarize and articulate key safety considerations and decisions.
- Ability to train others in departmental procedures and best practices.
Work Location
Hybrid model: Two days per week at the Porto or Cambridge office.
Why us?
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.
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Senior Manager Drug Safety/Pharmacovigilance employer: MoonLake Immunotherapeutics
Contact Detail:
MoonLake Immunotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Drug Safety/Pharmacovigilance
✨Tip Number 1
Familiarise yourself with the latest pharmacovigilance regulations and guidelines, especially those relevant to the UK, EU, and US. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the drug safety and pharmacovigilance sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss your experience with vendor management and oversight during interviews. Be ready to share specific examples of how you've ensured compliance and quality in outsourced activities, as this is a key aspect of the role.
✨Tip Number 4
Showcase your ability to lead cross-functional teams by preparing examples of past collaborations. Highlight how you’ve contributed to safety assessments and regulatory submissions, as teamwork is crucial for success in this position.
We think you need these skills to ace Senior Manager Drug Safety/Pharmacovigilance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in drug safety and pharmacovigilance. Emphasise your clinical drug development background, vendor management skills, and any specific therapeutic area expertise that aligns with the job description.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Discuss your understanding of pharmacovigilance regulations and how your previous experiences have prepared you for the responsibilities listed in the job description.
Highlight Key Competencies: In your application, make sure to mention your familiarity with PV processes, your experience with audits and inspections, and your ability to manage complex deliverables. Use specific examples to demonstrate these competencies.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the field of drug safety.
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Understand the Role Thoroughly
Before the interview, make sure you have a solid grasp of the Senior Manager Drug Safety/Pharmacovigilance role. Familiarise yourself with key responsibilities such as vendor oversight, safety surveillance, and compliance with GVP and GCP regulations. This will help you articulate how your experience aligns with the job requirements.
✨Prepare for Technical Questions
Expect to be asked about your knowledge of pharmacovigilance processes, regulatory requirements, and your experience with audits and inspections. Brush up on relevant regulations in the UK, EU, and US, and be ready to discuss specific examples from your past work that demonstrate your expertise.
✨Showcase Your Leadership Skills
As a senior manager, you'll need to demonstrate strong leadership capabilities. Be prepared to discuss your experience in managing teams, overseeing vendor relationships, and leading cross-functional collaborations. Highlight any successful projects where you took the lead and the impact they had on the organisation.
✨Ask Insightful Questions
At the end of the interview, take the opportunity to ask thoughtful questions about the company's drug safety initiatives, team dynamics, and future projects. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
