Medical Safety Review Physician
2 days ago
This position requires a medical professional with expertise in pharmacovigilance and clinical trials to perform medical review of Individual Case Safety Reports (ICSRs) from various sources. The successful candidate will evaluate the medical and clinical aspects of ICSRs to determine event seriousness, expectedness, and company causality, and identify potential safety signals at the single case level.
Key Responsibilities:- Evaluate ICSRs for all company products, including marketed and clinical development products.
- Perform regular medical case review for all ICSRs reported from any source, including clinical trials, literature, post-marketing studies, and post-marketing spontaneous adverse event reports.
- Assess reported adverse events (AEs) and serious adverse events (SAEs) and provide company causality assessment using clinical and global introspection methodologies aligned with global regulations.
- Review all AEs and SAEs to determine whether the events are accurately reported and captured as what occurred in the patient clinically and confirm that events are correctly coded with MedDRA and confirm seriousness criteria.
- Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to ICSRs.
- Review case narrative and medical contents for completeness, identify missing medical information or key data that impact medical understanding and evaluation of the case, and issue safety medical queries.
- Review and approve Analysis of Similar Events and provide company comments and assessment with medical analysis for SUSAR/IND Safety Reports.
- Provide overall case assessment and pharmacovigilance comment on ICSRs as needed.
- Identify important/critical cases with potential safety signals at single case level (i.e. first line signal detection), escalating Product Safety Lead Physician/Safety Scientist and Medical Monitors, and upper management as necessary.
- Issue urgent medical queries on urgent follow-ups, coordinating with Product Safety Lead Physician and Medical Monitors as required.
- Communicate with investigators and other AE reporters for urgent medical queries and follow-ups.
- Responsible for determining event term MedDRA coding for SAE reconciliation.
- Provide medical input and review RSI in Investigator Brochure.
- Provides the medical input and review needed for the creation of aggregate reports (PBRER, DSUR, PADER) as needed to support compounds in clinical development or post-approval.
- Contribute to preparation and review answers to safety queries from regulatory authorities and IRBs as needed.
- Contribute to preparation and review of any aggregate safety analysis in regulatory submissions as needed.
- Conduct training to new team members in medical review and help in managing Medical Case Review team.
- May act as Medical Safety Review functional representative on cross-functional projects.
- Contributing to metrics addressing internal timeline & work in progress performance (i.e. volume, quality, compliance and productivity metrics).
- Ensure effective ongoing quality assurance through ICSR review, feedback to ICSR team, issue escalation and continuous process improvement.
- Contribute to the root cause analysis of issues revealed by review of metrics.
- Support corrective and preventive actions stemming from compliance metrics review and other sources.
- Contribute to identification of standards, processes, controlled documents (including SOPs, Work Instructions, etc.) aligning with established and developing regulatory requirements for ICSR medical assessment and management.
- Contribute to the development of compliance targets and their ongoing determination.
- Contribute to and deliver training programs for Medical Safety Review Physician and ICSR personnel as required.
- Participate in and support internal and external audits and inspections including those by regulatory agency and business partners.
- Manage continuous improvement opportunities within Medical Safety Review and ICSRM management.
- Contribute to training, oversight monitoring, performance metrics review of ICSR vendor activities where applicable.
- Product Safety Lead Physician, Safety Scientists, Safety Study Lead, ICSR and ASR Management, Clinical Development, Clinical Operations, Safety OPS, Safety Systems.
No direct management responsibilities, but may be responsible for managing medical case review workload, distribution and monitoring workflow.
Computer Skills:Working knowledge of Microsoft Office Suite (e.g. Excel, PowerPoint, Visio, etc.), familiarity with safety database ARGUS and with MedDRA.
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