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.
Based in Europe and in the U.S., Celyad offers a stimulating working environment built around teams of highly motivated experts. Our Company surrounds itself with the best industrial and academic partners to explore the full potential of our technological platform.
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?
Celyad is looking for an enthusiastic:
Pharmacovigilance Associate (M/F)
The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the Clinical Trial Manager located in Belgium.
Role & Responsibilities
- Consistently apply and adhere to regulatory requirements and company policies to maintain pharmacovigilance system compliance. Undertaking projects, as assigned, in support of Celyad business objectives.
- Full orientation with the company clinical development program’ duties and the relevant operational activities.
- Monitoring pharmacovigilance operational business processes in line with the regulations controlling clinical trial drug safety and pharmacovigilance practices.
- Participate in Pharmacovigilance department and project status meetings and representing the Pharmacovigilance department during vendors` audits and during company’ inspection.
- Representing Pharmacovigilance department at internal and external meetings / conferences, communicating accountabilities, deliverables and achievements as appropriate.
- Reviewing case criteria to determine the appropriate workflow for case processing.
- Responsible for identifying, reporting and following up on adverse events, dealing with case process backlog and responding to authorities’ queries.
- Ensures effective Collaboration with pharmacovigilance & interfacing departments´ collaborators (QA / ClinOps / DM / RA / IT / QP) in order to ensure compliance and to develop and maintain in-depth knowledge on study-specific safety information and the ongoing clinical development program. corresponding disease and relevant study/program expertise via the department continuous training plan.
- Liaising with pharmacovigilance collaborators including Pharmacovigilance safety Physician who participate in the Safety Case management cycle business process for the relevant projects.
- Engaged in preparing pharmacovigilance specific Agreements (SDEA & SMP & PVQAP) / SOPs / WINs / aggregate reports / forms/templates relevant to the ongoing projects / studies.
- Maintains quality control of the handled safety data and liaising with Quality assurance (QA) department for the identified / recorded non-conformities and associated corrective and preventive action (NC/CAPA) for ongoing / continual improvement of the Pharmacovigilance Quality System (PVQAS).
- Review the source documents to detect inconsistencies / discrepancies in the handled safety information.
- Ensure accurate data entry of identified adverse event information (Initial / Follow-up) and the timely processing and reporting of adverse events in alignment with regulatory requirements and in line with relevant system operation procedures and working instructions
- Manage coding as required in accordance with MedDRA and WHO Drug Dictionary obligations.
- Ensures current conventions are followed upon entering Safety cases (SC) into the Safety database (SDB) and narratives writing for assigned SC as applicable.
- Provide queries to the investigation sites; and follow-up on outstanding queries and requests.
- Handling safety case submission to regulatory Competent Authorities, as required.
- Obtaining follow-up safety data/information from study sites as appropriate
- Assists in reconciliation of the safety and clinical databases to identify database discrepancies according to project-specific requirements.
- Performs case file creation, tracking (case closure / Follow-up information / submission), archiving and maintenance (paper / electronic) as indicated in the relevant procedures and working instruction.
- Records and tracks all adverse event fulfilling Celyad and authorities’ requirements, managing distribution of relevant communication procedures.
- Assists with generation/creation of presentation/training materials, as applicable.
- Coordinate internal pharmacovigilance training and escalates issues to management regarding compliance.
- Providing aggregate data (line listing and summary tabulation) as required, supporting safety signal management and the ongoing benefit-risk assessment.
Qualifications & Experience
- Fluent in reading, understanding, speaking and written English
- Other languages are plus point.
- BS/BA in life science (Biomedical / Pharmacological sciences)
- Degree in Nursing or Pharmacy with well-developed experience in Pharmacovigilance / Drug Safety.
- Industry experience in clinical development is highly desirable
- Relevant experience in the field of pharmacovigilance / drug safety business processes whether in pharmaceutical industry or clinical research organization (CRO).
- Solid understanding of / experience in pharmacovigilance in pre- / post-authorisation product life cycle either in pharmaceuticals, Clinical research organizations or health authorities
- The experience spectrum is including familiarity with safety database software / applications and coding process. Professional experience in dealing with PV tools including safety databases, Coding tools (MedDRA / WHODD) and SharePoint.
Skills & Competencies
- Develop and maintain expertise and knowledge for applicable corporate and global regulations guidelines [Eu (GVP / GCP / ICH) / non-EU (example: FDA].
- Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Maintains compliance with company policy, Standard Operating Procedures (SOPs) and Work Instructions (WIs),
- Excellent oral and written communication skills.
- Organization skills, autonomous and ability to work independently across multiple projects and work collaboratively with other team members.
- Meticulousness, eye for details, good interpersonal skills, Investigatory nature with ambition for development
- Proficiency in Microsoft Office Suite (Word, Excel, outlook and PowerPoint), database outputs.
- Ability to handle multiple tasks and meet due dates in a dynamic environment.
For more information about this position or about the Company, please contact us by email at email@example.com