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.
Your profile
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?
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 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com