Posted in Science 30+ days ago.
This job brought to you by eQuest
Location: Research Triangle Park, North Carolina
Position Title: Manager - Case Mangement Group
Working Location: North Carolina
Employment Status: Full time
Required Experience: 5 years
Required Education: Bachelors
Travel Required: 0%
This role acts as an expert in both global and local regulatory reporting requirements for post marketing adverse event and clinical trial SAE data. The role has responsibility and accountability for co-ordination and efficient delivery of expedited and periodic safety report activities within a large defined area. This role mentors/supervises and may line manage staff in both case handling and regulatory submission activities and is responsible for advancement of methodology/process improvement initiatives which impact CMG. This role works across a matrix environment and liases with US business customers, Central Safety Department, Regulatory and is an expert in safety processes.
• Responsible for all operational management of assigned projects. Co-ordinates and tracks workload within assigned area to ensure all CMG activities are delivered with high quality, efficiency and within the agreed timelines
• Conducts quality control and management monitoring of Individual Case Safety Reports (ICSRs) and processes (regulatory reporting, intake of US reports, follow-up) within CMG. Ensures monthly compliance monitoring is in place for FDA reporting and on-time rates, review for trends, issues addressed and CAPAs are implemented as appropriate
• May have line management responsibility including PDPs, reviews, mentoring, development planning.
• May act as the Case Management leader for process discussions and/or changes. Authors or provides significant input to SOPs, CMG Guidance documents related to FDA reporting requirements, CMG Argus User Guide.
• Responsible for oversight and coordination of ICSR processing and regulatory reporting for assigned area or group. This includes ensuring local and global processes are adequately covered for FDA reporting requirements
• Accurately prepares metrics for monitoring case quality and compliance.
• Demonstrates expert working knowledge of regulatory environment for all FDA reporting, as well as understanding of global reporting as it relates to ensuring global compliance. Requires collaboration with Central Safety Department, Systems Team and Configuration Team to ensure global safety database updates for any FDA requirements or regulation changes are accurate and timely.
• Provides guidance to business partners on pharmacovigilance SOPs and provides advice in interpreting local regulatory requirements.
• Represents US Case Management group on cross functional teams such as e.g. with Argus groups, Configuration group, CSD, Configuration Change Board, QPPV office for FDA late reporting of expedited reports
• Generates new ideas and proposals for implementation. Contributes to advancement of CMG methodology and process. Co-ordinates the implementation of new ideas/proposals
• Responsible for matrix managing the US Regulatory reporting team; daily expedited submissions to the FDA, issue and query management, oversight of training
• Mentors/trains less experienced staff on defined/targeted activities e.g. case processing, regulatory submissions activities
• Acts as a contact point to support internal assessments, audits, and inspections
• BA/BS degree in life sciences or medically related field.
• 5-6 years’ clinical safety or related experience
• Demonstrates technical expertise in safety processes including FDA Regulatory interpretation, SOPs, Systems/Argus working conventions
• In depth knowledge of GCP, clinical safety documentation and reporting of adverse events, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements.
• Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.