Riddhima Engineer Email & Phone Number

New York, NY, US

Princeton, New Jersey, United States

Greater New York City Area

Princeton NJ

Greater New York City Area

• Provide leadership and management of projects ensuring that communications and processes are harmonized for assigned projects.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
• Process all adverse event reports reported either spontaneously from any source or from a clinical trial.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
• Performing quality control (QC) of SAE reports for other members of the group.
• Executing routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.

Princeton, NJ

• Preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events.--Assisting in developing Safety Management Plans (SMPs).
• Cardiovascular Indications: Hypertension, Cardiovascular diseases: (Phase I/II/III)
• Oncology: Prostate Cancer; Breast Cancer, Colorectal Cancer, Lung Cancer (Phase II/III)
• Pulmonary Indication: Idiopathic Pulmonary Fibrosis: (Phase I/II)
• Neurology/Psychiatric Indications: Alzheimer; Fragile-X; Schizoprenia: (Phase II/III)
• Musculo-Skeletal Indications: Arthritis: (Phase II/III)

Princeton, NJ

-Maintained study-specific tracking spreadsheets (e.g. patient enrollment, regulatory documents, site visits).-Performed In house duties as assigned by the project manager.-Prepared regulatory binders for study sites.-Prepared materials and binders for Investigator’s Meetings.-Obtained, reviewed and processed regulatory and administrative documents from.

Bridgewater, NJ

-Formulated Transdermal products using various polymers, solvents and raw material.-Performed tests such as GC, IR, solids, viscosity on different types of solvents, raws and adhesives on various substrates.-QC and QA for drug delivery and Transdermal adhesives-Managed projects for Transdermal products-Prepared and analyzed laboratory reports and product.