reputed company Issue reputed company - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company FSP is looking for Issue Leads in the US or Canada! Job reputed company 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 by which we conduct 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. Job Responsibilities: reputed company Event Assessment and Investigation This individual will be accountable for the review and classification of submitted reputed company issues to reputed company if the QE reputed company has been met. He or she will ensure 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. This individual will also be responsible for completing the necessary documentation in the eQMS system regarding the assessment of the submitted events. Notification to Management This individual will be responsible for initiating appropriate escalation of Critical QEs reputed company necessary, ensuring that management is promptly and appropriately informed of reputed company events. The Issue reputed company will be 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 This individual will be 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 This individual will hold accountability 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 trends

Risk Mitigation Tracking reputed company and ensure implementation of risk mitigations and evaluate potential impacts to business. QUALIFICATIONS:

• BS – 7+ years or equivalent
• MS/MBA – 6+ years or equivalent

Previous Experience:

• 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.

EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply To This Job