Alice Macgregor Email & Phone Number

Sykesville, Md, Us

Gaithersburg, Md

Act as a liaison between the Departments of Patient Safety, Data Management, Clinical Operations, Clinical Programming, and the Safety Data Entry Site during the period of transition of responsibilities from Patient Safety to the latter four. Devise new processes for performing Serious Adverse Event (SAE) Reconciliation by merging the old process with the new.Learn differences between Ongoing Paper Based SAE dataflow and Electronic SAE data flow in order to provide guidance to Data Management and Clinical. Participate in and intermittently lead weekly meetings to inform Data Management Project Leaders (DMPLs) of the latest developments and to provide a question and answer period.Communicate with members of all departments to create an understanding of the origination of issues in order to solve problems. Provide guidance/consultation to DMPLs, Programmers, and Clinical Team membersDevelop and present training for members of the Data Management and Clinical teams regarding working procedures: Create reference materials for DMPLs.

Gaithersburg, Md

Perform clinical study safety support activities for assigned developmental programs per the PV Operation Support Specialist role with a reduced level of oversight and direction.Highlights:Sole member of Patient Safety to be awarded the MEDIMMUNE BRONZE AWARD for contributions to the BLA soft lock.Prepared and presented information to the Clinical Team to promote understanding of Safety Department processes, including SAE query development and tracking and SAE Reconciliation processes.Updated SAE training materials specific to assigned protocol.Presented SAE training to Clinical Project Managers from around the world.Provided guidance to Clinical Medical Monitor to aid in preparation for Oncology Medical Monitor training regarding general Patient Safety processes.Devised innovative methods to aid in data-cleaning efforts by collaborating closely with third party CRO.Created requests for datasets from Patient Safety Systems after evaluating the needs of all of parties; aided in the development of the Clean Case Tracker. Developed new processes for Oncology Safety Team due to accelerated timelines; Assigned specific tasks/cases to colleagues in effort to meet deadlines.Performed reconciliation between clinical database and safety database.Participated in individual Site Calls in order to communicate requirements needed to close open queries and achieve reconciliation between safety and clinical databases. Held weekly to bimonthly Reconciliation meetings with Global Safety Physician, Medical Monitor, Coding specialist, third party Data Cleaning CRO to disperse information and to resolve coding issues. Identified and prepared SAE case queries for assigned clinical trials in collaboration with Safety Physicians.Provided guidance and informal training for new PV Support Specialists. Updated study specific documents to reflect protocol amendments and changes in protocol staff.

Provided pharmacovigilance services for clients in a rapidly changing environment. Quickly adapted to revisions of client specific guidelines for several clients and their affiliates. Gained respect from peers and supervisors for great attention to detail and enormous dedication to the team's efforts. Motivated team to complete the Consumer Information Service Project on schedule. Made suggestions during team discussions to increase team efficiency. Completed projects on time or ahead of schedule. Received compliments from supervisor on writing style.Responsibilities include:Analyze and extract safety data from non-serious and serious spontaneous adverse event reports.Review clinical protocols and clinical trial data listings for extraction of safety data.Interpret medical conditions, lab results, and procedures.Ensure proper MedDRA coding of AE terms.Enter data into Empirica Clintrace and Argus databases.Perform searches of AE database for prevent duplication of information.Perform searches of product information labeling to determine event expectedness.Interact with reporters and clients as necessary to obtain clarification or follow-up information.Identify and notify clients of product quality issues.Compose complete narrative summaries for each AE report, including patient medical history, suspect and concomitant medication details, sequence of events surrounding adverse events, actions taken with suspect drugs, outcomes of events, and relatedness of events.Ensure timely submission of reports (MedWatch and CIOMS) to clients and to worldwide regulatory agencies in accordance with applicable regulations and PV agreements.Blind narratives as appropriate.Follow client specific guidelines and standards of operation.

Provided drug information, researched and wrote in-services, patient educational classes, and patient leaflets for long-term care pharmacy. Assisted in compilation of data necessary for pharmacy and therapeutics committee review. (Company sold September 30, 2008).

Guided homebuyers and sellers through the sale and purchase of properties. Communicated with other agents, buyers and sellers, mortgage officers, title personnel and home inspectors. Created sales brochures with Microsoft Publisher to profitably market listings.

Coordinated database for national AIDS Clinical Trial Information Service (ACTIS). Identified and abstracted AIDS-related "efficacy" clinical protocols from all FDA divisions. Made abstracts accessible to potential trial participants. Extracted drug-related information from NDAs and INDAs and incorporated into the Drug Product Reference File (DPRF). Provided information for the Antiviral Drug Product Review Division from the DPRF and other references.

Established and supervised new pharmacy for the north Community Mental Health Clinic. Represented the pharmacy on committee for quality assurance and infection control. Wrote for, edited, and compiled monthly pharmacy newsletter to educate hospital staff. Reviewed charts and recommended therapeutic alternatives for non-formulary drug requests. Taught weekly medication class to clients in the Intensive Day Treatment Program.