Requirements: English
Company: Panda International
Region: Strijp , Noord-Brabant
In this role, you challenge the complexities of clinical development, focusing on risk management and benefit-risk analysis to ensure the safety and effectiveness of innovative medical products.
You will be responsible for:
- Conducting benefit-risk analysis and contributing to risk management throughout product lifecycles.
- Collecting, appraising, and analyzing clinical data related to medical products.
- Writing clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCF).
- Collaborating with internal (project owners, regulatory, statisticians, post-market surveillance, risk management, etc.) and external (clinical consultants, regulatory agencies, etc.) stakeholders to ensure comprehensive clinical evidence analysis.
- Ensuring appropriate dissemination of clinical evidence through Clinical Study Reports (CSRs), CERs, and PMCF Reports.
- Supporting clinical trials and product approvals in the USA, EU, and ROW.
- Leading clinical risk assessments from ideation to market introduction.
- Reviewing and optimizing workflows, SOPs, and document preparation procedures for the Clinical Development department.
Your Profile:
- Preferably an M.D., Masters, or Ph.D. in Biomedical Science or a health-related field with 35 years of experience in the medical device or pharma industry.
- Expertise in benefit-risk analysis and clinical risk management.
- Experience in vigilance reporting and/or harm reviews for medical products.
- Training and experience in medical writing, systematic reviews, and clinical data appraisal; experience with MDR-compliant CERs and PMCFs is a plus.
- A demonstrated working knowledge of GCP, ICH guidelines, ISO14155, FDA regulations, and EU regulations.
- Experience with clinical investigations design, biostatistics, and research methodology.
- Proven ability to deliver clinical results on time, within budget, and in compliance with SOPs and regulations.
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.