Theradex Oncology has designed and performed more than 350 early-phase oncology trials to date. As a full service CRO, Theradex Oncology knows how to assist its clients in developing successful strategies and execute studies in cancer treatment. Our mission is to ensure that new opportunities in drug development have the very best chance to be of benefit to mankind, with a vision to make cancer a livable disease. With 42 years of experience focused entirely on oncology, we are passionate specialists. We understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Our head office is based in Princeton, NJ, USA, while our European operations are managed from our London office

The primary responsibilities of this position include, but are not limited to, the following:

• Manages the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document. This includes but is not limited to:
  • Reviews SAE reports and any supporting documents for accuracy and completeness.
  • Enters safety data into the Theradex Safety Database.
  • Writes patient narratives.
  • Codes Serious Adverse Events accurately using MedDRA.
  • Identifies significant missing information from reports and ensure its collection.
  • Ensures case receives appropriate medical review.
  • Prepares follow-up correspondence.
  • Ensures cases that require expedited reporting to regulatory agencies are processed within the timelines identified in the SMP.
  • Provides independent QC of SAE reports processed by the team
• Notifies the Sponsor and clinical team of SAEs, as required.
• Prepares safety reports for Sponsor approval, regulatory submission and investigator notification.
• Submits safety reports to regulatory agencies, Central Ethics Committees and Investigators, as required.
• Maintains study-specific records for SAEs and safety reports, including the Theradex safety database.
• Reconciles the Theradex Safety and clinical databases and coordinate with data management and Clinical Research Associates to resolve discrepancies.
• Coordinates the review of safety data by the Medical Monitors at pre-determined intervals.
• Actively participate in Pharmacovigilance team meetings.
• Provide after-hours monitoring and processing SAE reports, if required by sponsors
• Ensure audit preparedness and support regulatory inspections
• Maintain up-to-date knowledge of protocol and scope of work for assigned projects

Level of Education

Master in Pharmacy or life science field or equivalent e.g. Biological Sciences, Pharmacy, Nursing (required)
PhD in Pharmacy or life science field or equivalent (preferred)

Prior Skills and Experience
0-2 Years of Experience: This can include internships, research projects, or part-time roles in pharmaceutical companies or clinical research organizations

Multilingual (French, Spanish, Italian, German, Dutch) (preferred)

Skills and Competencies
Attention to Detail: Critical for accurately monitoring and reporting adverse drug reactions.
Analytical Thinking: Important for evaluating complex data and identifying potential safety issues.
Communication Skills: Necessary for effectively conveying findings and collaborating with team members.
Time Management: Essential for handling multiple tasks and meeting regulatory deadlines.
Problem-Solving Abilities: Useful for addressing unexpected challenges and improving processes.
Proficiency in Microsoft Office: Especially Word and Excel, for data management and reporting.
Fluent knowledge of written and verbal English
Highly organized and result-oriented
Ability to work independently as well as in a team environment
Prior experience of working with clinical databases such as ARGUS (preferred)

This job does not offer company sponsorship 

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.