We are currently seeking a Medical Reviewer to support our work in Aggregate Reporting and Signal Management. Within the role you will:

• Conduct the review and assessment of Individual Case Safety Reports (ICSRs) obtained from clinical trials, spontaneous, and solicited reports.
• Determine regulatory reportability of cases obtained from clinical trials, spontaneous, and solicited reports within the assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
• Perform triage of cases and determine seriousness and relatedness across products as assigned
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
• Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
• Conduct an assessment of litigation cases across products as assigned
• Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
• Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
• Prepare and review periodic aggregate safety reports
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet
• Lead/support PDS post-marketing safety study activities
• Carry out signal detection activities and evaluation
• Follow up on reconciliation of discrepancies.
• Perform literature review activities when trained and assigned.
• Participation in local or global project teams, including on-time delivery of assigned responsibilities
• Oversee, improve, and contribute to procedures and performance
• Collaborate in the development, review, and initiation of SOPs
• Interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
• Identify documents and appropriately resolve out-of-scope work as directed by senior management
• Maintain a working knowledge of GCPs and regulatory requirements relating to clinical and PV teams to assure compliance with regulatory standards
• Mentor other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion, and integrity, support Senior Management’s leadership of both the department and the company
• Read and acknowledge all necessary Navitas Life Sciences Standard Operating Procedures (SOPs) as required.
• Execute administrative operational tasks as required
• Provide oversight on operational activities and a sound understanding of project plans/documents
• Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues

• Sound knowledge of the PV domain and working experience with Risk Management Planning Reports, Signal Detection, and Evaluation, and the preparation and review of Periodic Aggregate Safety Reports
• Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
• Excellent organizational and time management skills