Safety Officer

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for a fixed-term contract for 6 months for a Safety Officer role. This role can be home-based anywhere in Romania, France, the UK, Portugal, or Spain.

PURPOSE AND MAIN RESPONSIBILITIES

Purpose

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. Reports to Senior Manager SVG, Manager SVG or Principal Safety Officer as applicable.

Responsibilities

Be under the supervision of the SVG Manager, and a Principal/Senior or Advanced 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/sponsors) to resolve discrepancies arising from the reconciliation process

· Relevant query management: 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 Safety Officer is the Case Owner

· Ensures adequate correspondence with reporters and Medical Reviewers

· Perform/Review submission/transmission of cases to client/sponsors, 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.

· 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

· Lead or act as back-up for assigned safety projects, acting as the main contact for safety activities

· Ensure budget control for assigned projects; 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 their appendices such as the SAE Form, etc.

· 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 monthly reports and other activity reports related to projects ensuring the quality and metrics of the activities handled.

· Ensure a priority interface with the client/sponsors as Project Safety Lead/back-up (where assigned). This responsibility can be shared with the Manager SVG, a Principal/Advanced or Senior Safety Officer/Physician during customer contacts.

· Conduct advisory and monitoring processes with the client/sponsors, particularly based on the information provided by the Head of Department and the Quality Assurance department

· Monitor and manage outstanding safety queries

· Maintain safety filing and archiving systems for assigned projects

· Complete study close-out activities

REQUIRED SKILLS AND QUALITIES

Essential Work Experience, Qualifications and Knowledge

• English required
• CRO/consultancy/healthcare experience
• Appropriate education (preferably degree level in e.g., Biomedical Science, Pharmacy, Health/Life Sciences, Medical Biology or Nursing)

Desirable Work Experience, Qualifications and Knowledge

• Experience using ARISg / Safety Easy or other safety database applications
• Safety case processing
• Safety report submissions

For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page -

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.