Lynn Mcintire Email & Phone Number

San Diego, California, Us

Cambridge , Ma, Us

Responsibilities include a leadership role within the Drug Safety and PV department, proactively evaluating safety for assigned assets and updating safety information for the asset within clinical documents as well as aggregate reports and regulatory documents in collaboration with the Safety Physician and Medical Director. Lead safety scientist responsibilities include representing PV at clinical study team meetings. Risk management activities for the assigned asset also include periodic safety review of safety information clinical trials with study team and providing recommended updates to clinical documents. Also a member of the NDA Clinical and Labeling Working Groups in support of Integrated Summary of Safety for CTD and Label for assigned asset. Drafted and updated Drug Safety SOPs.

Cambridge, Massachusetts, Us

Responsible for working collaboratively with the Head of PVRM to assess, track and document the ongoing benefit-risk profile of all products in development. This includes authoring and coordination of aggregate reports (e.g., DSUR), coordinating Safety Review Team (SRT) and Executive Safety Review Committee (ESRC) meetings, contributing to signal detection activities, developmental RMPs, and clinical development and product registration activities. Responsible for review of safety sections for clinical operations documents (e.g., IBs, Protocols, ICFs, CSRs, clinical IMPDs). Participation in routine medical management activities of coding and safety listing reviews for ongoing clinical studies and review of summaries of data read outs for DEC and SMC meetings. Oversight of updates to SMPs and safety reporting responsibilities with CRO. Review of SAE narratives. Representation of PVRM for study team meetings. Established a SharePoint site for department and system for storage for PVRM documents. Review, development, and routine updates of department SOPs, Charters and Safety Governance document.

Tokyo, Jp

Global Safety Scientist. Contribute to the production of aggregate reports of high quality, Safety Review Team coordination, signal detection activities, and clinical development and product registration activities. Ensures responsibilities as Global Safety Scientist are in accordance with global regulations and in collaboration with the GSLs and other key GDS, Clinical, NCD, GMA and R&D stakeholders.

Peabody, Massachusetts, Us

• QA/reconcile all SAE's related to the current NDA submission to ensure accuracy and completeness • Provide Safety Operations support to assist current staff as needed with the case processing vendor transition • Provide support and as needed, direction to the CRO's responsible for supporting the active clinical trials at our client • Oversee temporary employees during data migration project. • Collaboration in the drafting and approval of PV SOPs, NTFs. • Provide aggregate reports to Data Management, Clinical Operations, and Medical Monitors. • Other duties as assigned

Us

Using clinical study report guidelines, converted safety and efficacy data gathered during clinical studies into a well-organized, well-displayed unambiguous report. Prepared document sections using Word to provide text, tables and figures. Finished sections submitted to McNeil for inclusion into the CSR.

Troy, Michigan, Us

Part-time, relief, Medical Information Specialist responsible for managing Adverse Event Reports and providing response to medical inquiries from consumers and health professionals in support of currently marketed products as needed.

Us

Responsible for managing Adverse Event Reports, including evaluating and monitoring reports, providing analysis of safety data, and preparing submissions to Regulatory authorities. Responsible for developing and providing response to medical inquiries from customers and health professional insupport of currently marketed products.

Troy, Michigan, Us

Responsible for managing Adverse Event Reports and for developing and providing response to medical inquiries from consumers and health professionals in support of currently marketed products.

Philadelphia, Pa, Us

Responsible for managing the clinical pharmacokinetics service, coordination of aminoglycoside dosing grogram for all hospital patients and assisting with promoting safe and cost effective antibiotic usage within the institution. Served as a preceptor to Philadelphia College of Pharmacy Students and provided didactic teaching for the Thomas Jefferson College of Allied Health.

Us

Coordinated the adverse drug reaction program and made recommendations for their avoidance. Provided drug information both informally and formally. Monitored drug use. Developed drug therapy guideline/protocols to optimize patient care. Provided consultations regarding drug therapy. Provided educational activities. Participated in committee activities. Continually evaluated new drugs making recommendations for formulary additions and deletions. Documented clinical activities and drug cost savings.

Boston, Ma, Us

Provided high quality pharmaceutical care to pediatric patients via clinical pharmacy services, supervising satellite pharmacy functions, and teaching (graduate and undergraduate pharmacy students). Also responsible for coordinating the undergraduate clinical clerkship program at New England Medical Center.

Pinehurst, North Carolina, Us

Planned, scheduled, evaluated and supervised the patient care activities of Pharmacy Services. Coordinated Pharmacy acitivities with other services. Participated in the development, organization, implementation, coaching and evaluation of plans for providing drug therapy and assisted in the development of staff that met those plans. Continually updated departmental policies and procedures. Assisted in the development, maintenance and evaluation of the department's quality improvement program.

Member of the VA Central Office AIDS Committee.

Dayton, Ohio, Us

Pharmd

B.S., Pharmacy