Glaxosmithkline Work Values

Daily Duties at Glaxosmithkline:

Wrote, produced and implemented safety data for IND study reports, PSUR's and end of study reports. Presented safety information at more than 15-25 investigator meetings with more than 800 attendees, Triaged safety reports for my assigned products, entered safety data and produced reports for world wide regulatory authorities., Performed regulatory and IND queries for regulators and medical monitors, Reviewed and approved protocols, CDP, risk management plans, adjudication board charter, PVP plans, SAE forms, laboratory manuals and investigator brochure for compliance on safety information. Created clinical narratives of SAE's and reviewed and approved narrative for final submission., Performed more than 25 reconciliations on clinical ntrials and globally unblinded clinical trial data. Instructed employee on performing reconciliations and global unblinding of clinical trials, Provided and supported information on clinical nand CRP personnel ndealing with safety. Processed SAE's, pregnancy reports, IND reports and entered into Oceans/Argus database within specified timelines for FDA and world wide regulatory authorities, applied knowledge for safety reporting based on 21 CFR and ICH guidelines with MedRa coding WHO dicitionary coding. Cross trained in all therapeutic areas in clinical postmarketing and consumer health or over nthe counter products. Assisted other team members on IND submissions, data entry, narratives on tight reporting timelines, Back-up for two team members products while on clinical.

What they like about Glaxosmithkline:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

pharmacovigilance, Sr. clinical research associate, Immunology, Oncology, Virology, Endocrinology, Cardiac markers, Data reconciliation, Clinical trials, Global delivery, Protocol development, Medical case management, Risk management, Clinical narratives, SAE reporting, Medical devices, IND queries, Regulatory reporting, Global unblinding, Safety database, Adverse event reporting, 21 CFR ICH, MedRa coding, WHO dictionary, IND reports, Regulatory submissions, Clinical study reports, Perodic Safety Update Reports PSUR, Quality auditing, Site Management, Monitoring, Teaching adults, Investigator meetings, Regulatory compliance, Internet recruiting, Drug development, Query resolution, Triage case workload, Oracle Argus II

Skills

These are some of the questions we asked our climbers about their experiences with Glaxosmithkline: