The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The Aixial Group occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.
We are currently looking for an enthusiastic and talented Advanced Safety Officer. This role can be home-based anywhere in Romania.
PURPOSE AND MAIN RESPONSIBILITIES
Purpose
Advanced Safety Officers are responsible for collecting, monitoring, processing and distributing safety reports for investigational and marketed products. They are also responsible for safety management of assigned projects, taking a lead role in accordance with Aixial contractual obligations and Standard Operating Procedures. Additional responsibilities include mentoring and training. Report to Senior ManagerSVG, ManagerSVG or Principal Safety Officer as applicable.
Responsibilities
Ensure the good performance of vigilance activities (pharmacovigilance, materiovigilance & medical devices, cosmetovigilance, nutrivigilance), of medical information, of writing periodic reports for research or authorized products, which are entrusted to them, in accordance with the specifications contracted with customers, in compliance with regulations, ethics, quality and compliance with procedures and deadlines.
Ensure a total traceability of the actions carried out with an optimal level of quality. Trace all relevant information on the activities to the Head of vigilance (or designee) and to the client, according to the communication procedures established in Aixialand for the project. Adopt a prospecting mindset, promote the image of society outside. Assist in the updating and evolution of Aixial’s applicable procedures and templates. Are involved in the regulatory watch for the activities provided by the department.
The Advanced Safety Officers can be a liaison for the company's staff in case of security problems as well as external subcontractors, working in close collaboration with colleagues from the SVG department as well as those from other departments (Clinical Operations, Data Management, Biostatistics, Quality Assurance, Medical Affairs etc). Be under the supervision of the SVG Manager, and a Principal/Senior Safety Officer/Physician on activities or projects requiring specific or technical expertise or experience.
PRINCIPAL RESPONSIBILITIES
1. Management of safety reports
· Screen adverse event reports and perform triage accordingly
· Perform data entry within the safety database, to include MedDRA coding and narrative writing
· Perform quality review of cases within the safety database (completeness, accuracy and appropriateness of reportability), providing feedback where appropriate
· Correspond with health care professionals regarding adverse events in writing and by telephone as appropriate
· Prepare evaluation of "expectedness / listedness" criteria with reference documents
· Liaise with data management (or Client) to resolve discrepancies arising from the reconciliation process
· Identify important missing information and ensure collection and monitoring
· Ensure that cases have followed all the necessary and appropriate steps, including medical review and submission if necessary, if the Advanced Safety Officer is the Case Owner
· Ensures adequate correspondence with reporters and Medical Reviewers
· Perform/Review Submission/transmission of cases to clients, regulatory authorities, ethics committees, investigators and any other relevant persons of the project, as per the applicable legislation and guidance and within the specific deadlines set out in the Safety Data Exchange Agreement / Safety Monitoring Plan
· Participate in the preparation and writing of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Addendum of Clinical Overview (ACO) etc. The Advanced Safety Officer may have a lead role in this activity for a given project. In this case, they will be responsible for the planning, obtaining the necessary data and the smooth running of the drafting of the document within the deadlines and quality required.
· Prepare and review periodic safety line listings
· Perform submission of aggregate reports to regulatory authorities, ethics committees and investigators as per the applicable legislation and guidance
· Accurately complete relevant project trackers
2. Project oversight
· Manage a project as Project Safety Lead act as a main contact for safety activities for the client, support the development of safety tools and documents for this project and their implementations, supports Billing and Financial Status development, establishes workplans, attends Safety Review Meetings, Safety Committees / DSMBs (where required), participates in Client Meetings and proposes, if needed, any improvement solution. This responsibility can be shared with the SVG Manager or a Principal/Senior Safety Officer.
· Ensure compliance with the commitments of the projects entrusted to them (budgets, deadlines,figures). Ensure the service for the client while remaining exclusively within the framework of the specifications agreed between the parties. If necessary, alert the Head of Vigilance (or designee) for any additional requests from the client, raise out of scope work and change orders as appropriate
· Perform project start-up activities, such as preparation of Safety Data Exchange Agreement (SDEA), Safety Monitoring Plan (SMP) and SAE Form
· Prepare and perform safety training at investigator meetings
· Prepare and maintain project specific documents and other procedural documents as required for assigned projects
· Represent SVG at assigned project meetings
· Oversee safety processing and reporting, ensuring compliance with internal and regulatory timelines
· Prepare or Support and review monthly regulatory reports and other activity reports related to projects, (previously drafted by theSafety Officer) ensuring the quality and metrics of the activities handled.
· Participate in defining the human resources needs for the projects on which they are assigned in consultation with the SVG Manager/Head of vigilance.
· Conduct advisory and monitoring processes with the client, particularly based on the information provided by the Head of vigilance and the Quality Assurance department
· Ensure the implementation of Medical Information: respond to healthcare professionals and patients/consumers, enter data into the dedicated database, and participate in the establishment and updating of FAQs
· Monitor and manage outstanding safety queries
· Maintain safety filing and archiving systems for assigned projects
· Complete study close-out activities
3. Safety oversight
· Maintain awareness of and compliance with current guidelines/legislation on clinical safety, clinical trials and other relevant topics
· Understand and apply Aixial’s or Clients' standard operating procedures (SOPs), instructions andguidelines Contribute to the development and revisions of the applicable Aixial quality documents (procedures, instructions, models) regarding Vigilance, make them known and apply within the team.
· Participate in the monitoring of regulations concerning Vigilance activities in pre- and post-marketing setting – Regulatory Intelligence activities .
· Monitor safety mailboxes to ensure compliance as well as correct and timely action
· Register with EudraVigilance and regulatory authorities as applicable
· Support the set-up and validation of new and updated safety databases
· Support ongoing maintenance of safety databases
· Perform searches of safety databases and other relevant electronic tools, using scientific interpretation skills to assess the data
· Generate reports/listings from the safety database for reconciliation, aggregate reports, ad hoc requests and other deliverables
· Perform case unblinding for individual cases and end of study unblinding as applicable
· Support literature review and signal detection as required
· Act as a point of contact for regulatory authorities and ethics committees
· Ensure a solid understanding of the data entry conventions in Aixial Clients safety databases and actively participate in their development.
· Can perform MedDRA and WHO DD coding for Data Management/clients.
REQUIRED SKILLS AND QUALITIES
Essential Work Experience, Qualifications and Knowledge
Desirable Work Experience, Qualifications and Knowledge
People Leadership
Technical skills
For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
