Safety Reporting Associate

The GSS Safety Reporting Associate is responsible for the efficient management of individual case safety reports (ICSRs) and periodic safety reports, such as annual safety reports (ASRs). This includes submitting reports to global regulatory authorities, and distributing to study site investigators and central ethics committees (ECs) / institutional review boards (IRBs). The role involves overseeing all aspects of safety report submission, including receipt, tracking, preparation, submission, distribution, and filing. Additionally, the Safety Reporting Associate may contribute to the development and review of safety reporting and safety management plans. They will also provide backup support to the GSS Safety Associate, assisting with tasks such as safety report receipt, acknowledgment, tracking, triage, safety database entry, and filing. Responsibilities:

• Individual and Periodic Safety
• Responsible for ensuring the timely, high-quality, and compliant submission of all safety reports for which GSS is responsible, including individual case reports and periodic reports such as Annual Safety Reports (ASRs) and Development Safety Update Reports (DSURs)
• Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
• Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work.
• Participates in project teams, and where required provides training and support to team members in respect of safety reporting.
• Monitoring industry best practices. Maintaining advanced knowledge of global and local regulations and guidelines, to ensure that safety reporting for studies and relevant GSS processes complies with all applicable.
• Ensuring inspection readiness and participate in audits and inspections as
• Supporting the GSS department and Leadership as
• Assist with project-specific audit and inspection preparation, and actively participate in audits and
• Investigate quality concerns, address non-conformances, and develop and implement Corrective and Preventive Actions (CAPAs) related to safety reporting as necessary.
• Assists in generating reports/metrics and alerts the GSS manager to any quality or timeline
  
  Education - Bachelor's degree or equivalent formal academic/vocational
• Previous experience - 2+ years or equivalent combination of education, training, & experience that provides the necessary knowledge, skills, and abilities for the role, or a relevant combination of education, training, and experience. Preferably, experience of safety report distribution and submission, as well as healthcare administrative.
• Training - Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines.
• Exceptional attention to detail with a focus on accuracy and meticulous
• Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
• In-depth understanding of global and local pharmacovigilance (PV) regulations and legislation, covering both pre- and post-marketing phases.
• Understanding of medical terminology and familiarity with coding dictionaries g. MedDRA
• Strong project management, interpersonal, verbal and written communication
• Proficient in Microsoft Office programs (Word, Excel, PowerPoint) and knowledgeable about relevant applications including safety databases (experience with Veeva Vault Safety is a plus), EMA EudraVigilance, CTMS, EDC, EMA CTIS, UK MHRA IRAS, Advarra Longboat, and website submission