Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, EyeD Pharma is hiring a Clinical Evaluation Specialist / Clinical Project Leader.
- Write and contribute to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, summary of safety and clinical performance reports (SSCPs), PSUR, and other related documentation.
- Perform systematic literature searches in appropriate databases and documentation.;
- Evaluate and summarize clinical evidence including data from sources such as clinical investigations, literature, design verification/validation data, product complaints, post-market surveillance, risk, and post market clinical evaluations.
- Maintain thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interpret, evaluate, and incorporate information from various sources including literature, clinical data, and medical references.
- Collaborate with team members and stakeholders in planning for and supporting CER related projects and processes.
- Effectively communicate and collaborate with Pharmaceutical Development, Regulatory Affairs, Medical Affairs, and Quality in completing clinical evaluation project related deliverables.
- Participates in strategic discussions regarding the design of clinical investigation studies and post market clinical follow-up.
- Lead and manage clinical investigation and post market clinical follow-up activities./span>
- Identify risks for the successful conduct of the studies and implement solutions.
- Write and contribute to product Usability Plan and Use/misuse FMEA.
- Lead and manage usability/human factor studies.
- Participate in Risk Management activities and Post Market Surveillance.
- Review IFUs, patient guides, Risk management files, Clinical Evaluation Protocols, Clinical Evaluation Reports, physician training materials, ensuring alignment of risk information.
- Contribute to responses to queries issued by notified bodies or competent authorities.
- Contribute to necessary documents for regulatory submissions.
- Ensure quality in all deliverables and documentation with attention to detail, consistency, and integrity of data.
- Ensure compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14971, MEDDEV 2.7.1, IEC62366, MDR, and EU and FDA guidance documents) and applicable internal standard operating procedures.
- A university degree, preferably in Life Sciences, biomedical engineering, or Pharmacy.
- PhD is an asset.
- Minimum of 5 years of experience in a similar position within a Medical Device company.
- Excellent written and verbal communication skills in English and French.
- Must have a thorough knowledge of clinical evaluation concepts, practices, and regulations (ISO14155, MEDDEV 2.7.1).
- Must have a thorough knowledge of medical device regulation and guidelines (ISO13485, ISO14971, IEC62366, MDR, and EU and FDA guidance documents).
- Therapeutic experience in ophthalmology is an asset.
- Dynamic, team player, as well as structured and goal-oriented person.
- Excellent analytical skills and ability to manage complex tasks and time effectively.
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company.
- Full time.
Please send your CV and cover letter in English to : firstname.lastname@example.org