- Pharmacovigilance and drug safety roles from medical review of serious single cases; signal detection and their medical evaluation and aggregate responsibilities with PSUR, ASR and QSR production.
- Signal detection activities with data mining, evaluation and report production
- Multiple therapeutic product responsibilities of both clinical and post - marketing events involving oncology, hepatology, respiratory, cardiovascular, antifungal and HIV drugs
- Competency in MedDRA coding and the triage of serious reports
- Contributed to the development of ongoing safety monitoring plans and of SOP associated with pharmacovigilance activities.
- Broad clinical trial experience which included protocol review, IRB coordination and the review of completed case report forms.
- Past clinical trial internal auditing case documentation and compliance as related to oncology studies (ECOG)
- Cross-trained in safety databases including Oracle-AERS, Roche Advent System, and Argus
- Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events
- Assesses the relationship between drugs and adverse events
- Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review
- Participates in the training of the Safety Specialist and Coordinators
- Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely medical review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities
- Director Physician for Medical Review of Oncology and Lipitor Products
- Performs Medical Review and Triage and Assessments of serious and non serious cases in Invent Health ARGUS Safety Database with accurate MEDRA coding of events in a timely manner providing scientifically sound medical comments
- Knowledge of CFR and ICH Guidelines for drug safety surveillance with review for scientific correctness information processed on adverse events Ensure AE reports are processed and evaluated in compliance with regulations, guidelines, SOPs and internal processes.
- Cooperate with safety professionals in Europe, Americas and India to ensure that product safety profiles are acted upon appropriately and in a timely manner
- Provide medical support and advice to non-physician personnel
- Lead Physician for Ferrosan and Alacer Project for integration with Pfizer Safety Data Base
- Performs Medical Review and evaluation of serious and non serious cases in Pfizer ARGUS Safety Database with correct choice of events and their coding
- Performs confirmation of choice of events and their MEDRA Coding for assigned cases prior to Medical Review and final submission
- Performs the correct process for the migration of Alacer and Ferrosan cases into the Pfizer Argus Safety Database
- Performs Medical Review of Enbrel Cases together with the Active Moiety Cases
- Performs single case medical review and evaluation in AERS safety database with proper coordination with Senior Specialists and Medical Monitors regarding events and coding issues
- Plays an active role in signal detection management plans for future use in the proper identification and reporting of possible signals with possible submission to safety committee
- Performs MEDRA Coding of events for reconciliation of Cubicin cases
- Involved in the preparation of the new Medically Significant Listing
- Actively involved in the harmonization of event terms in the updated Company Core Data Sheet
Confidential, Springfield, New Jersey
- Single case medical review including medical evaluation and CIOMS II comments as related to causal relationship and alternative etiology
- Preparation of PSUR’s sections VII through IX, Annual Safety Reports and Quarterly Reports
- Generate follow-up queries as related to complete medical analysis for a specific event
- Established as an authority for triage and case processing to align safety follow-up with specific events of interest and targeted questionnaires
- Generated signal evaluation for presentation to the Safety Review Board utilizing historical safety information provided in PT summary reports delineated by System Organ Class (SOC).
- Identify SUSAR, Death and Life Threatening cases and submit them in a timely manner
- Evaluate all serious reports for potential signals that may require a change to the existing safety profile of the product.
- Review quarterly line listings with signal specialist to identify any potential safety risks
- Medical Literature review of printed articles to identify potential case
Medical Review Officer
Confidential, Princeton, New Jersey
- Assess and review all adverse event cases, provide feedback for follow-up and potential signals as related to current safety profile of the product
- Provide other departments with medical opinions regarding products & procedures
- Educate and instruct personnel in medically related issues including triage and regulatory guidance on serious classification.
- Complete SAE investigations of possible alternative causality for closure & reporting following data entry and QC.
- Participate in the preparation and submission of PSUR and labeling documents