Oversee daily PV operations, including adverse event case processing, aggregate reporting, and safety data management. Ensure timely and accurate processing of adverse event reports in accordance with global regulatory requirements. Contribute to the set up and maintenance of Veeva Systems, including CDMS, Safety, and CTMS. Develop and maintain SOPs and work instructions to ensure consistent and compliant PV practices. Develop and implement CAPA plans as necessary. Provide training and mentorship to new or more junior members of PV and safety CRO case processors. Foster a collaborative and high-performance team environment. Identify and implement process improvements to enhance efficiency and quality. Contribute to the development and execution of the strategic plan for the PV department and support the operational budget, ensuring efficient allocation of resources.

Provide oversight management of safety CRO for all aspects of SAE processing and provide training and guidance information where necessary. Serve as the subject matter expert for pharmacovigilance. Collaborate with Clinical Operations, Project Managers, Data Management, and clinical CRO for multiple studies. Review MedDRA and WHODrug coding monthly for multiple studies and provide suggestions for coding. Review and provide input on DSUR, CSR, IB, Protocol, and Signal Reports. Assist with event reconciliation. Review AE and SAE data in the clinical database (EDC) for data cleaning purposes. Write patient safety narratives for CSR. Review and write SOPs. Review and write Technical Agreements and Pharmacovigilance Agreements (PVA). Provide safety data for company-wide presentations.

Provide pharmacovigilance support and case processing duties as directed. Provide training for colleagues on case processing and narrative writing. Design Narrative Writing Style Guide. Perform Quality Assessment of narratives and data entry for processed cases. Review coding for WHODrug and MedDRA for accuracy. Perform triage, query sites as needed for data, and communicate with medical monitors and other safety team colleagues.

Provide pharmacovigilance support and case processing duties as directed. Perform Quality Assessment of narratives and data entry for processed cases by colleagues and vendors. Perform medical coding review for WHODrug and MedDRA for accuracy. Perform triage, query sites as needed for data, and communicate with medical monitors and other safety team colleagues. Perform end of study unblinding.

Review serious adverse events, concomitant medications, and medical history for proper MedDRA and WHODrug coding for multiple global studies. Communicate with clinical operations team to address outstanding queries and review cases for closure. Write CSR narratives.

Responsible for the daily activities of SAE management including narrative writing, database entry, query generation, and case closure activities. Responsible for writing Safety Management plans and designing forms for study start-ups. Responsible for reconciliation between clinical and safety databases. Responsible for various levels of client interactions and attending team meetings. Responsible for study close-out activities and electronic file transfer.

Responsible for all aspects of post-marketing pharmacovigilance (PV) activities including triage, case processing, quality control checks, and following up on serious and non-serious adverse events submitted by multiple sources (spontaneous, direct lift, solicited, and literature). Responsible for providing oversight and leadership to PV and call c!enter teams in the absence of management, generating monthly aggregate reports, and providing client support. !

Responsible for processing, collecting and analyzing serious adverse events and pregnancy repots from clinical trial reports, including generating site queries and coding information in MedDRA.

Responsible for reviewing SAS and Business Object Reports of Clinical Trial Data for individual subjects enrolled in sponsored clinical trials. Responsible for identifying missing or inconsistent data (e.g., AEs, medications, etc.) and generating queries in Oracle Clinical Database for Study Physician review.

Responsible for collecting, monitoring, processing, and distribution of serious adverse events reports within time frames set forth by Sponsors and/or regulatory authorities. Evaluated all safety cases for potential expedited reporting to FDA and/or other regulatory authorities. Assists with SAE reconciliation between the safety and clinical database.

Responsible for composing narratives based on clinical research study information, entering data into safety database, generating queries to obtain outstanding information and updating narratives and safety database with follow-up information. Responsible for updating SAE procedures, forms, and guidelines.

Prepared narratives based on clinical research study information, including client specific SAER form and supporting medical records. Responsible for entering data into safety database.

Reviewed medical records for pertinent event data and composed chronologies and narratives for pharmaceutical litigation. Researched and summarized medical literature.

Participated in post-marketing safety projects with marketed pharmaceutical products involved in class-action litigation and targeted investigation of adverse events of special interest. Responsible for collection, processing, follow-up, analysis, and regulatory reporting of events for marketed products and investigational compounds. Responsible for entering information into client's safety database and properly coding (MedDRA) events.

Responsible for handling phone queries, providing medical information, and identifying adverse drug reactions.

Performed nursing tasks in a variety of clinic settings.

Performed nursing tasks in an ambulatory Surgery/Oncology clinic.

Responsible for the daily operation of Pediatric Clinic and staff.

Responsible for the daily operation of Pediatric Clinic and staff.

Researched health and wellness topics and wrote educational materials.

Performed assessments and assisted providers with procedures.