Global Safety Scientist
2 weeks ago
Job Purpose
The global safety scientist role is responsible for providing scientific expertise to safety surveillance and risk management activities for MoonLake products in clinical development. The role actively contributes to setting the strategic direction within drug safety and to the development of safety standards and processes.
Key Accountabilities:- 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) and highlight potential safety signals.
- Contribute to the strategy and review of safety assessments and for signals or issues (including product quality) or in response to Regulatory Authority requests.
- Lead the collection of material for periodic reports e.g. DSUR and contribute to the risk evaluation and benefit-risk assessment for the product.
- In collaboration with the Director of Drug Safety, contribute to the development and maintenance of the development RMP and CCDS.
- Act as the safety representative in assigned clinical study teams, including providing safety input to design, conduct data analysis and interpretation.
- Work in close collaboration with the safety vendor to ensure appropriate case processing.
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, Biologics License Applications/BLA, Variations, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with the director of drug safety.
- Participate in and provide input for Data and Safety Monitoring Board (DSMB) or internal Drug Safety Committee (DSC) meetings, as applicable. In partnership with the Director of Drug Safety, support presentation of important safety issues to the Drug Safety Committee (DSC), and other internal and external review and governance committees as needed.
- Responsible for MedDRA version change impact assessments.
- Work collaboratively and flexibly with the Director of Drug Safety to complete safety deliverables and activities to ensure continuity of safety support.
- Contribute to the development and maintenance of safety related systems, processes and procedural documents.
- In collaboration with the director drug safety work to ensure compliance with GVP, GCP and global regulatory requirements.
- Support audits and inspections for pre-inspection requests as well as during audits and inspections.
Education
- Qualified healthcare professional or Life Sciences graduate. Formal medical qualifications (e.g. MD; MB BS; MB ChB; GMC registered or GMC permissible) or PhD in a topic relevant to the position is beneficial.
- Five or more years of clinical drug development experience in the biopharmaceutical industry or a related sector (e.g. academia; CRO; etc). Preferably including at least 2 years of experience in a clinical drug safety-related role.
- Previous experience in pharmacovigilance, including advanced knowledge of PV regulation and cross-functional working. In-depth knowledge of global regulatory requirements for safety reporting and labelling.
- 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.
- Possessing a strong knowledge of international pharmacovigilance requirements, specifically in the UK, Europe and US and prior experience of regulatory authority interactions.
- Demonstrates independence and high competence in the conduct of all safety science responsibilities.
- Proactively takes on responsibility for more complex deliverables.
- Strong orientation towards process improvement and cross-functional teamwork.
- Demonstrated ability to work within a multi-disciplinary team of peers and outside experts.
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
- Ability to effectively train others on departmental practices and processes.
- 2 days a week in our central Cambridge or Porto office
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. Our Core Values We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other. We unlock value: We aspire to create long-term value for investors and communities. #J-18808-Ljbffr
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