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.
* Demonstrable 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.
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