Glaxosmithkline Work Values

Daily Duties at Glaxosmithkline:

GLAXOSMITHKLINE Research Triangle Park, North Carolina February 2002- November 2014 Principal Clinical Safety Scientist • Sole safety scientist for all oncology products. • Managed more than 30 compounds from drug development, preclinical, pharmacokinetics through Phase I-IV. • Served as sole safety scientist on enrollment of 3,000-6,000 patients in large Tykerb clinical trial(s); and credited with obtaining new drug applications (NDAs) for it, as well as for: Paxil CR, Arannon, Votrient, Lamictal XR, Requip for restless leg syndrome, and Requip XL for Parkinson’s disease. • Given multiple products and therapeutic areas from preclinical, pharmacokinetics, Phase I-IV; and produced and implemented safety data for investigational new drug (IND) study, periodic safety update, (PSUR), and end of study reports narrative writing and NDA submissions. • Collected and analyzed clinical trial safety data, including working with: multiple vendors on lifecycle phases from II-III for Requip; and complex sharing agreements of study responsibilities for Requip XL. • Investigated and located Federal Drug Administration (FDA) written agreement to submit reports on listed events for Requip that required notification to hundreds of global sites. • Evaluated precursor to Inform database, Remote Data Access, for Paxil CR studies and reconciliations. • Created and presented PowerPoint slides on safety information at more than 25 investigator meetings, each with 400-800 physicians and nurses, who were going to be running the trials, in attendance. • Performed regulatory and IND query searches for regulators and medical monitors producing aggregate reports for submission. • Reviewed and approved clinical developmental plans (CDPs), risk management plans, adjudication board charters, pharmacovigilance plans (PVPs), serious adverse event (SAE) forms, protocols, laboratory reference manuals, and investigator brochures for compliance on safety information. • Created clinical narrative of SAEs and reviewed and approved others’ narratives for final submission. • Generated over 25 clinical trial final reconciliations and globally unblinded data; and trained others to do so. • Provided and supported information to clinical and contract research personnel dealing with safety. • Processed SAEs and pregnancy, IND’s, litigation and literature reports; and entered them into Ocean/Argus database within timelines specified by FDA and worldwide regulatory authorities. • Applied knowledge of coded federal regulations (CFRs) to safety reporting based on and international committee of harmonization (ICH) guidelines using MedRA WHO dictionary coding. • Produced over 22 IND reports in one day for Tykerb, along with other assigned oncology products. • Met different worldwide reporting timelines for entering safety data into database for 30 plus assigned products. • Performed reconciliations on National Cancer Institute’s old clinical trial data, resulting in an NDA. • Assisted team members on IND submissions, data entry, and narratives aggregate reports within tight reporting timelines. • Expert in post marketing, consumer health, and medical devices for all GSK products and all therapeutic areas. • Identified, investigated, and reported on call center employees’ lack of training on change in reporting issued in corrective and preventive plan action (CAPA) based on regulatory audit and six years overdue. • Acted as a liaison to Brazil site by assisting with safety issues and database queries. • Worked with 100 SDE (licensing agreement) partners to clarify post-marketing reports. • Signal evaluation risk management on early clinical projects. • Sole safety scientist for epilepsy, pain, neuropathy, central nervous system, depression, arthritis and every oncology product. • Responsible for training CRA’s and sending them to sites for issues with SAE’s in clinical trials. • Controlled release of payments to sites that experienced SAE’s depending on resolution of events. • Performed more than 800 reconciliations in multiple therapeutic areas.

What they like about Glaxosmithkline:

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

Tags

clinical trials, pharmacovigilance, clinical monitoring, aggregate reports, PSURS, employee traing, global delivery, vendor management, site management, patient safety, adverse event reporting, case report form development, risk management, query resolution, global unblinding, medical case management, regulatory submissions, regulatory audits, protocol writing, protocol review, informed consent review, informed consent approval, study tool development, drug return, investigator recruitment, investigator selection, present at investigator meeting, 21 CRF, ICH-GCP, clinical study reports, global clinical matrix team participation, remote monitoring, pre-study visit, interim monitoring, closeout visit, study audits, regulatory query resolution, NDA approval, IND, data reconciliations, IRB submissions, medical device

Skills

pharmacovigilance, clinical trials, aggregate reports, IND subissions, PSURS, data reconciliations, protocol writing, IRB submissions, regulatory submissions, employee training, vendor management, global delivery, Presentation at investigator meetings, global unblinding of study, patient safety, medical case management, EDC databases, case report form design, investigator brochure writing, serious adverse event design, MedRa coding, writing pharmacovigilance plan, investigator brochure review, informed consent review, site audits, site selection, interim monitoring, study closeout visit, drug accountability, medical device, laboratory tests, hepatitis markers, drug labeling, PBER, drug destruction, compliance, regulatory

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