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Director Pharmacovigilance
2 months ago
The Director Pharmacovigilance & Drug Safety serves as the Pharmacovigilance/Drug Safety Lead for MoonLake’s clinical development programs and as advisor to the Executive team and all internal functions regarding MoonLake’ clinical development activities.
Key Accountabilities:
- Establish and maintain the safety strategy for assigned projects/ products based on strong product knowledge.
- Participate in the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety data activities including CROs.
- Be accountable and ensure (alongside the study Medical Director) that the medical oversight/safety management plan between the company and the appointed clinical CRO is robust and implemented in accordance with the agreed procedures.
- Provide medical evaluation of Individual Case Safety Reports (ICSRs) alongside the study Medical Director/Clinical Science Specialist for assigned products, for safety monitoring of global scientific/medical literature for assigned products and for providing input to and review of periodic aggregate safety reports.
- Work with study Medical Director/Clinical Science Specialist in aligning query generation.
- 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.
- Develop and recommend changes to safety related procedures, ensuring adherence to those procedures.
- Provide oversight in the production and validation of appropriate safety data output from the safety database for required safety deliverables.
- Act as the safety representative on cross-functional development teams including study teams.
- Engage with external organisations, key opinion leaders and advisors and provide strong oversight of outsourced activities related to clinical safety.
- Act as Drug Safety Committee Secretary, own the DSC charter and its implementation. Work with the Chief Medical Officer (DSC Chair) in delivering effective DSC meetings.
- Provide safety related training to company employees as is required.
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.
- Experience working with vendor teams and providing oversight of outsourced safety activities.
- Strong experience with (safety or others) issue management
- Prior therapeutic experience in dermatology, rheumatology, immunology or GI would be an advantage.
- Proven understanding of GCP, specifically from a daily operational perspective.
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.
- Sound knowledge in safety data bases, familiarity with safety data entry platforms, adverse event collection process and case processing.
- 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.
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
