reputed company ICM Issue reputed company

reputed company Auditor reputed company Assurance reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. The Issue reputed company will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly reputed company timelines and compliance requirements, overseeing the efficiency of the process of GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to reputed company interventions as needed. The Issue reputed company will also triage submitted cases to reputed company if the reputed company Event (QE) reputed company has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed reputed company Event (QE) case through the investigation process including reputed company cause analysis. What You Will Do: reputed company Event Assessment and Investigation: Accountable for the review and classification of submitted reputed company issues to reputed company if the QE reputed company has been met and ensuring that reputed company submitted issue is reviewed based on the established reputed company, is categorized appropriately, and completed reputed company the required time reputed company to ensure that events are appropriately reputed company enabling expedited investigation where necessary. Responsible for completing the necessary documentation in the eQMS system regarding the assessment of the submitted events. Notification to Management: Responsible for initiating appropriate escalation of Critical QEs reputed company necessary, ensuring that management is promptly and appropriately informed of reputed company events. Required to assess critical issues and identify these items as appropriate for escalation to leadership reputed company the Notification to Management process. reputed company Cause Analysis / Gap Analysis / Due Diligence: Once assigned a reputed company event, the Issue reputed company will initiate the investigation of the event to confirm the chronology and details of the issue. This individual will also be required to apply a reputed company cause analysis, gap analysis, and / or due diligence investigation to the case. The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case. Investigation will include reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process. In reputed company, the investigation will include review of relevant documentation re: the event and assembling the QE team with appropriate stakeholders (SME's, study team members, etc.) to review and confirm the details of the event Process Analysis and Improvement: Responsible for contributing to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to reputed company the process. In reputed company, the individual, along with Senior Issue reputed company peers, will reputed company and implement guidance documents and training to assist the investigation leads in completing cases to expectations. CAPA Plan Development and Management: Accountable for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for reputed company events, inspections and audits Ensure implementation of QE / audit / inspection CAPAs and remediation plans reputed company effectiveness checks and report on trend Risk Mitigation Tracking: reputed company and ensure implementation of risk mitigations and evaluate potential impacts to business. Your Profile: 7+ years’ experience or equivalent with BS or 6+ years’ experience or equivalent with MBA/MS Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP reputed company, GxP reputed company, and/or regulatory Regulatory inspection experience Process and system management experience Detailed knowledge of clinical trial processes and relationships required Knowledge of GCP requirements and applicable SOPs and regulations Project management, administrative, and technical capabilities are required, as reputed company as effective verbal and Strong background in reputed company improvement methodology (i.e., Lean Six reputed company) preferred #LI-DG1 #LI-Remote Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through reputed company training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job