Safety Director - 1047

Job Summary

The Safety Director is a hybrid role working for both the medical and safety departments. For Safety, they are responsible for the medical review and evaluation of draft individual case safety reports (ICSRs) produced by the Global Safety Services (GSS) team. The review is centered on providing medical evaluation, assessing the relationship between investigational agent and reported event, ensuring accurate interpretation of reported information, confirming accurate dictionary coding and assessment of expectedness/listedness and ensuring medical coherence of the safety narrative. The role includes assessing safety reports for emerging safety signals. Additional duties include the review of study safety management Plans (SMPs) and supporting the GSS team in process enhancements and optimization.

For medical, they are responsible for the delivery of medical monitoring services, including, but not limited to, working with clinical project teams to monitor the safety of ongoing studies, and support database locks. The Safety Director will attend regularly scheduled meetings as required and respond to site, sponsor and Health Authority questions. They may attend and present at Investigator meetings, review CRFs, present study updates as needed, train in-house staff and project teams, design and implement safety monitoring plans, conduct database listings (DBL) final reviews, review blinded tables, listing & figures (TLFs), review protocol deviations, and participate in all DBL meetings as assigned. The Safety Director will review final TLFs, work with the medical writer(s) to review & revise Clinical Study Report (CSR) documents, review discussion and conclusions, and participate in comment resolution meetings.

Essential Duties & Responsibilities

• Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents.
• Oversees and is responsible for the medical monitoring services on assigned projects.
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities.
• Ensures delivery of medical/clinical direction to investigative sites per contract deliverables.
• Prepares medical and safety plans for clinical trials/services.
• Reviews and analyzes safety and efficacy trends.
• Builds up, maintains, and develops the internal therapeutic training in their assigned studies.
• Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
• Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts.
• Oversees reviews and directs medical and safety sections of regulatory document submissions.
• May participate in Investigator meetings Team Meetings, DSMB and Safety Review Meetings
• Contributes to the development of medical-related standard procedures and working activities.
• Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review.
• Contribute to development of Safety Management Plans (SMPs), ensuring they are consistent with company SOPs, global PV regulations and guidance from applicable regulatory agencies, ICH and GCPO.
• Perform medical review and assessment of ICSRs including serious adverse events (SAEs), adverse events of special interest (AESIs), overdose, and pregnancy exposure from clinical trials
• Evaluate causality, severity, and expectedness of safety events in accordance with protocol, SMP and regulatory guidelines.
• Identify and assess emerging safety signals and trends across clinical study data
• Provide medical input into safety narratives, ensuring that they accurately describe the available data and are medically coherent
• Check that the coding of adverse event terms in the safety database using the MedDRA dictionary has been completed accurately.
• Confirm the GSS Safety Lead's assessment of expedited reporting requirement, including determination of expectedness/listedness against the relevant refence information, has been assigned correctly.
• Participate in safety review meetings, data monitoring committees, and study team discussions, where requested
• Supporting the GSS department and Leadership as required:
  a. Ensuring inspection readiness and participating in project-specific audits and inspections
  b. Investigate quality concerns, address non-conformances, and develop and implement Corrective and Preventive Actions (CAPAs) related to safety reporting as necessary
  c. Assists in generating reports/metrics and alerts the GSS manager to any quality or timeline concerns.
  

Qualifications

• Education: Medical degree (MD/MBBS), preferred

• Training: Clinical experience; specialty training (e.g., internal medicine, oncology, neurology, cardiology) preferred.

• Certification

  
  
  
  

  • Strong understanding of clinical trial methodology, drug development, and global PV regulations. Qualification or Certifications preferred.

  • Medical Degree, active medical license, preferred

  
  
• Experience
  
  
  
  • Ten (10) years industry experience (CRO preferred) including 4 years as a Medical Monitor and 4 years in a Safety Director role
  • Experience in medical review of ICSRs, including clinical study reports
  • Ability to interpret complex clinical and safety data and communicate clear medical judgments.
  • Provision of review within safety database
  
  

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).