Terri L. Rhoades, Mt, Ccra,Mlt Email & Phone Number

Raleigh, Nc, Us

Specialist on working with pharmaceutical companies , IT companies to solve problems with databas- es, in the pharmaceutical, biotech and medical device industry. Consulted on a pharmacovigilance database problem with an oncology pharmaceutical and helped address issues concerning the loss of oncology narratives across 8 clinical trials. Consulted with a IT database company which was not a IT problem but a lack of training in pharmacovigilance by the CRO. Provided feedback to a financial advisor concerning how to find a biotech company for an entrepreneur wanting to invest in and the regulatory process for development.

Attending Networking EventsResearching Industry LeadersTracking Industry Trends such Medical Devices, Oncology and Consumer Health Products.Participating in Industry Discussions

New York, Ny, Us

Senior Case Manager (Temp) / Safety SpecialistPharmacovigilance specialist in medical writing, aggregate reports, medical devices and pharmacovigilance. Responsible for Oncology clinical trial, 200 generics and writing SAEs from literature reports.

OperationsSafety Specialist / Associate ManagerPharmacovigilance specialist on several pharmaceutical projects for complex Phase II oncology, cardiovascular and cystic fibrosis.Trained on post marketing protocols as quality reviewer and quality auditor.Worked with another CRO on EDC database access and training.Corresponded with pharmaceutical companies over submission of regulatory reports and critical impact on study.Advised other employees on medical information important to the suspected unexpected adverse reaction.

Provided pharmacovigilance input into an IT proposal for a patient support/mail order pharmacy bid. Provided guidance to business entrepreneur mentor member concerning funding for a medical device

Brentford, Middlesex, Gb

Noteworthy record of performance by increasing annual revenue between $43M and $1.7B with $43M/year for Requip XL and Tykerb, $100M/year for Votrient, Lamictal XR, $300M/year, Paxil CR, which generated $1B , Treximet with annual revenue of $1.12B. Compiled record of “no findings” from various agencies for all monitored clinical trial sites and regulatory auditsSole safety scientist for all oncology products in clinical trials and safety surveillance, Tykerb, Votrient, Azerra, Mekinist, Tafinlar, Arranon., Leukeran, Alkeran and Chlorambucil.. Responsible for writing safety adverse events, reconciliations, clinical narratives, signal evaluation risk management and IND report submissions for 30 compounds.. Contributed IND safety aggregate reports, reconciliations, narratives, and safety data submissions in clinical report for final submission.. Created aggregate reports for all studies in clinical trials. Expertise in virology, neurology, oncology, muscular skeletal, endocrinology, metabolism, inflammation, psychiatry, respiratory, gastroenterology and radio pharmaceuticals. Specialists with pharmaceuticals ,biologics, vaccines, medical devices, post marketing and consumer health products.Reviewed, created 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. Pharmacovigilance from drug development, preclinical, pharmacokinetics through Phase I, II, IIIa, IIIb and IV.

• Desigend monitoring conventions for clinical trials. Monitreod ankylosing spondylitis study fori mmunex for Embrel NDA. • Reviewed and monitored case forms for completeness, accuracy with source documents, clarity and legibility and conformity to protocol, • Resolved CRF discrepancies at the site while monitoring or by phone or fax. • Reported adverse events promptly to sponsor and collaborated with the medical monitor to resolve any protocol violations.• Completed monitoring of 15 sites on a Phase IIIB Randomized Double blind study for Takeda. • Effectively monitored sites for study selection, study initation, study closeout visits and drug return or destruction according to protocol guidelines.• Recruited investigators into clinical trials.• Reviewed study documents, CV, 1572, regulatory documents for completeness.• Independent auditor for dermatology clinical trial of investigational product at the sites.• Verified serious adverse information was complete and verified documentation at the site.

Wilmington, Nc, Us

• Monitored pediatric clinical trials of Bristol Myers Squibb Metformin, extending patent for three years for product generating an annual revenue of $1.7B..Reviewed and approved over 38 local IRB informed consents in a pediatric clinical trial while monitoring 15 sites for 3 protocols for Bristol Myers Squibb rescue protocol on tight timelines of in a Phase II/III obtaining Metformin NDA for pediatrics.• Designed drug inventory spreadsheet before the hoklidays insuring all drug orders were submitted. • Coordinated regulatory training of employees from quality assurance.• Completed all closeouts for Bristol Myers Squibb study including additional sites.• Performed site selection, interim monitoring and closeout visits and trained new CRA"s.• Approved site destruction of investigational product.• Completed site closeout visit for another team member.

Seongnam-Si, Gyeonggi-Do, Kr

• Audited 2 year completed HIV trial for Bristol Myers Squibb and was submitted for NDA. • Monitored 9 sites two protocols in a pivotal Phase II & III salvage study,• Found investigators for a worldwide HIV study involving 4000 via internet searches.• Coordinated training, monitored sites and managed sites accirdubg ti SOP"s and 21CFR and ICH.• Approved drug for destruction at investigator sites.

Bachelor'S Degree, Biology, General

Cls From Nca, Medical Technology

Associate'S Degree, All Areas Of The Laboratory

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