Terri L. Rhoades, Mt, Ccra,Mlt personal email
- Valid
Pharmacovigilance Specialist, Clinical SafetyConnect with me using: ►►► rhoades.terril@gmail.com ◄◄◄ All Invitations to Connect Welcome, LION – LinkedIn Open Networker****************************************************************************************************Recruiters, HR Managers, Hiring Managers connect with me to get access to my network deep in industry leadership.****************************************************************************************************Specializing in taking the chaos of clinical trials and producing new drug applications (NDA's). Highly motivated, detail oriented Pharmacovigilance Specialist with 19 years experience with clinical trials and obtaining new drug applications. Skilled at reviewing and approving aggregate protocol documents, creating safety reports, and coding with MedRa and WHO dictionary. Strong organization skills. Consistently submit reports on time and within tight deadlines. Excellent oral and written communication. Work collaboratively in matrix team environment. Experienced in post marketing pharmaceuticals, biologicals, vaccines, medical devices and consumer health or over the counter products. CCRA with 4 years monitoring HIV, hepatitis, virology, oncology, dermatology, immunology and diabetesPlayed instrumental role in increasing annual revenues by $1.35B and $79M as sole Safety Scientist for Tykerb and Requip, respectively; and $43 M/year increase by submitting Requip XL for Parkinson’s disease; the latter two while working with complex vendors.Served on team credited with $100M/year Votrient revenue increase by producing clinical safety report Aggregate reporting on all clinical studies.Technology skills include Microsoft Office Suite Powerpoint, Excel, Word: Databases Oracle Argus Iii, Inform, Medidata, RAVE, Electronic Data Capture, CTMS, RAMOS, Query DatabaseTo discuss opportunities, please call me at (919) 457-3454.
Contractor
-
Consultant And Pharmacovigilance Specialist And Medical WrierContractorRaleigh, Nc, Us
-
Consultant/Pharmacovigilance Specialist/Medical WrierContractor Mar 2017 - PresentSpecialist 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.
-
Founder | Pharmacovigilance Specialist, Clinical SafetyPharmacovigilance Drug Safety Leadership, Raleigh-Durham, North Carolina Area 2017 - PresentAttending Networking EventsResearching Industry LeadersTracking Industry Trends such Medical Devices, Oncology and Consumer Health Products.Participating in Industry Discussions
-
Pharmacovigilance Specialist, Clinical Safety, Medical WriterGreen Key Resources Nov 2016 - Feb 2017New York, Ny, UsSenior 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. -
Pharmacovigilance Specialist, Clinical Safety ,Associate Manager, Medical WriterCro Jul 2015 - Jan 2016OperationsSafety 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.
-
Pharmacovigilance Specialist Consultant, Medical WriterIndépendant Pharmaceutical Professional Feb 2015 - Jul 2015Provided 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
-
Principal Clinical Safety Scientist, Medical WriterGlaxosmithkline Feb 2002 - Nov 2014Brentford, Middlesex, GbNoteworthy 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. -
Clinical Research Associate IiPharmanet 2000 - 2002• 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.
-
Clinical Research AssociatePpd 1999 - 2000Wilmington, 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. -
Clinical Research AssociatePharmaresearch Corporation 1998 - 1999Seongnam-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.
Terri L. Rhoades, Mt, Ccra,Mlt Skills
Terri L. Rhoades, Mt, Ccra,Mlt Education Details
-
Radford UniversityGeneral -
Rex Hospital School Of Medical TechnologyMedical Technology
-
Wake Technical CommunityAll Areas Of The Laboratory
-
Wake Technical Community CollegeLinkedin
Frequently Asked Questions about Terri L. Rhoades, Mt, Ccra,Mlt
What company does Terri L. Rhoades, Mt, Ccra,Mlt work for?
Terri L. Rhoades, Mt, Ccra,Mlt works for Contractor
What is Terri L. Rhoades, Mt, Ccra,Mlt's role at the current company?
Terri L. Rhoades, Mt, Ccra,Mlt's current role is Consultant and pharmacovigilance specialist and medical wrier.
What is Terri L. Rhoades, Mt, Ccra,Mlt's email address?
Terri L. Rhoades, Mt, Ccra,Mlt's email address is rh****@****ail.com
What schools did Terri L. Rhoades, Mt, Ccra,Mlt attend?
Terri L. Rhoades, Mt, Ccra,Mlt attended Radford University, Rex Hospital School Of Medical Technology, Wake Technical Community, Wake Technical Community College.
What are some of Terri L. Rhoades, Mt, Ccra,Mlt's interests?
Terri L. Rhoades, Mt, Ccra,Mlt has interest in Fda Regulations, Animal Rescue, Yoga, Drug Development, Environment, Patient Safety, Reading, Science And Technology, Walking, Animal Welfare.
What skills is Terri L. Rhoades, Mt, Ccra,Mlt known for?
Terri L. Rhoades, Mt, Ccra,Mlt has skills like Clinical Trials, Clinical Research, Pharmacovigilance, Drug Development, Clinical Monitoring, Medical Devices, Patient Safety, Data Reconciliation, Global Delivery, Protocol Development, Analysis, Regulatory Submissions.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial