We bring breakthrough pioneering therapies to patient with life threatening diseases.
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of CAR-T therapies. Our ambition is to develop a unique platform to offer new treatment options to cancer patients, addressing multiple targets, optimizing the signaling domain, and weaponizing the T-Cell.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
While Celyad is headquartered in Mont-Saint-Guibert, close to Brussels, the company is clinically active across Europe and the U.S and we constantly seek to showcase our Research & Development activities in the international area through publication and congress presentation. Consequently, Celyad offers a stimulating working environment with the opportunity to interact with colleagues and stakeholders across the globe involved at each step of the product development process.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
The successful candidate will be based in Mont-Saint-Guibert (BE).
Role & Responsibilities
- Responsible for managing internal (long term vision) and external staff allocated to operational PV activities, creating a highly efficient team across outsourced resources.
- Contribute to the development of global Medical Safety/Pharmacovigilance strategies
- Implement a pharmacovigilance system fully compliant with the applicable worldwide Health Authority PV regulations.
- Contribute to the selection of PV vendors to support an outsourced PV business model. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Establish a system for prevention and correction of deviation to compliance with internal and external stakeholders
- Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
- Develop and/or maintain a set of safety SOPs related to the processing and reporting of SAEs from clinical trials and marketed products to ensure performant and compliant PV processing, integrated with other PV and non-PV SOPs.
- Contributes to the signal detection, benefit-risk profile assessment and aggregate reporting activities.
- Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
- Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
- Ensures specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant PV Vendor.
- Represents drug safety as a leader on project teams, other departments.
Qualifications & Experience
- Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience, advanced Life Sciences Degree
- Minimum of 5 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 3 years in managerial role in drug safety
- Experience in oncology (I/O) preferred
- Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources
- Through knowledge and experience in all aspects of safety reporting for clinical trials
- Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools.
- Operational expertise with ARGUS preferred.
- Level will be commensurate upon experience and qualifications
Skills & Competencies
- Very strong attention to details
- Work precisely as per procedures, rules and regulations
- Objective and analytical
- Planning & Organizing skills
- Team spirit and ability to work both independently and across-functional team
- Strong communication skills
- Hands-on attitude
- Work from the Celyad office, with flexible work schedule/WFH ~ 2 days/week)
For more information about this position or about the Company, please contact us by email at email@example.com