A dedicated Clinical Affairs professional with dual Master degree in Pharmacology (pre-clinical and clinical) and in Regulatory Affairs (Drugs, Medical Devices and Biologics).
05 years of work experience in Pharmacovigilance, Clinical Development, Medical Writing, Vendor Management (VMT) and regulatory affairs with good project management skills.
A Mentor, a trainer with leadership skills, working with cross function teams, a SME and regulatory teams.
Independently authored, patient narratives of Clinical Study Reports (CSR), reviewing study protocols.
Experience in reviewing clinical documents, ICF, CRF, FDA forms clinical trials phases, generating queries and SAE management.
Sound knowledge of clinical trials, drug development, PV regulations, GVP, FDA, EMA, ICH and GCP guidelines.
|Clinical Research, Clinical Study Reports (CSR), Investigator Brochure (IB), Clinical Trials Phases, Clinical Study Protocol and study design, HIPAA compliance and PHI on the CEC projects, Qualified Investigator Undertaking (QIU) Form, Site delegation logs (DORs), informed consent forms (ICF), Investigator Brochures (IB), Drug development plan, GCP and GDP compliance, Electronic Data Capture (EDC), IRB requirements, Clinical documentation. Proficient in operating MS- Word, Excel, PowerPoint, Outlook, SharePoint, Adobe Acrobat.|
Serious Adverse Events (SAE) reporting
Clinical Study Reports (CSR)
Investigator Brochure (IB)
Informed consent forms (ICF)
Case Report Forms (CRF)
Investigator Brochures (IB)
ICH GCP and GDP, FDA guidelines
Electronic Data Capture (EDC)
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