Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. 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 Qualifications: 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 At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.