Dr. Ujwala Salvi Email & Phone Number

Buffalo, Ny, Us

Mumbai, Mh, In

Nucleon Research a Global Clinical Research Organization (CRO), based in Mumbai (India) and New York (USA) specialized in providing Prompt, Affordable, Consistent, Ethical and Reliable (PACER) services for Pharmaceutical, Medical Devices, Nutraceutical and Consumer Health Care Companies. We provide Customized & Comprehensive Solutions using Innovative and Unique Approaches to cut through the core of our Client’s needs.Our Expertise and Professional services includes:1. Site Management for Global Clinical studies2. Clinical Trial Management & Site Monitoring operations2. Clinical Data management 3. Medical Information Call Center 4. Medical, Safety / Regulatory WritingOur expert team includes skilled group of research professionals holding degrees and certifications in Medicine, Pharmacy, Pharmacology, and Computer Sciences, who have undergone cross training across domains, thus equipping them to design and implement customized and efficient solutions to meet any indigence in clinical research.

Charlotte, Nc, Us

I am Leading Clinical Operations, Regulatory Affairs, and Business Development to support the clinical development programs for the investigational lead drug candidate in company sponsored and investigator-sponsored trials.Responsible for Finance, Leadership, Project Management, and program oversight to plan and conduct high quality clinical trials concurrently in accordance with DCGI, CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions.

Mumbai, Maharashtra, In

Prime focus to provide world class Skill development in Clinical Research / Pharmacovigilance and Pharmaceutical domain, with unique curriculum which combines academic, Case Studies, practical learning through various software & with its internship schemes with Global MNC Pharma companies, Clinical Research Organization (CRO) & KPO Industry.

Princeton, New Jersey, Us

End to end Pharmacovigilance/Safety Writing & Management of Medical Information call center (MICC) for ADR Reporting, Product Complaints and Medical Information for Biopharmaceutical and Medical devices

Mumbai, Maharashtra, In

Support end to end Pre-Sales & Business Development activities across Pharmaceuticals & CRO sector • Identify New Business Opportunities, Potential Markets / New Clients and turn this into increased business in international and domestic market. • Understand the company's goal and purpose to enhance the company's performance• ROI & P&L Management, Arrange regular Business Reviews with clients and identify their needs• Forecast sales/revenue targets and ensure they are met by the team, Performance reviews with Management team. • Analytic in Generic Drug Development

Ahmedabad, Gujarat, In

Full spectrum of Clinical Research Services, providing one stop solutions for your drug development needs, under one roof. End-to-end Clinical development solutions across various segments such as - Neutraceuticals, Pharmaceuticals, Biotech, Generic, Biological, and Medical devices.Compliance with regulatory requirements for DCGI, USFDA, EMA, MHRA, ectSupport end to end Business development activities for complete CRO, Preclinical and toxicology • Identify New Business Opportunities, Potential Markets / New Clients and turn this into increased business in international and domestic market. • Understand the company's goal and purpose to enhance the company's performance• ROI & P&L Management, Arrange regular Business Reviews with clients and identify their needs• Forecast sales/revenue targets and ensure they are met by the team, Performance reviews with Management team. • Training and Development: New Drug Development, Clinical Development, Medical Writing, Clinical Operations• Feasibility in Generic Drug Development

Ahmedabad, Gujarat, In

Business Development: Performed end-to-end Regulatory Writing and Filing activities on various Medical Device projects. 1. Developed proposals in response to requests for proposals (RFPs), Request for Quotation (RFQ) and NDA (Non Disclosure Agreement) for new customers.2. Formulated the business plan for new projects and ensured adherence to key financial objectives of PBT, NPV, IRR etc. over the life cycle 3. Worked with the team to track analytics (website, email, and surveys) to make data-informed decisions.4. Partnered with Director of Marketing and Sales & Marketing Manager to create a budget that meets the requirements to achieve revenue goals aligns with company valuesOperation Management: Handled the complete process flow of Device manufacturing from RFQ and raising quotation to final dispatch of the project to the customer. Quality Assurance: Served as Management Representative (MR), and implemented ISO 9008:2001 and ISO/TS 16949:2009 Quality Management System that provides continual improvement, emphasizing defect prevention, reduction of variation and waste in the supply chain for the design, development, production and service of products. 1. Responsible for Writing, Reviewing and Development of process SOPs for operations, store and purchase department, marketing, design and production.2. Served as SPOC for communications and handling of customer complaints for correction, adequate root-cause and corrective and preventive action

Teaneck, New Jersey, Us

1. Medical Writing: Independently serve as the primary LEAD author and performed Medical Writing activities (Protocol, CSRs [Phase II and Phase III mainly in oncology], SAE Narratives [over 2000 narratives mainly in oncology, Ophthalmology and respiratory], CTD Narratives, ASRs and PSUR, Clinical Overviews and IB updates) as specified by effective SWI/SOP on the assigned project in a timely and efficient manner2. Research, write and edit Drug Risk Management Plans, Drug Safety aggregate reports, such as PSURs, PBRERs3. Develops and track medical writing project timelines, processes, and working standards; ensures company SOPs, templates, style guides, etc, are aligned with industry best practice4. Performed peer review/quality control checks and audit as and when specified and be responsible for quality and timelines of the Study MWs’ activities/deliverables as designated/allocated in the project5. Quality Assurance: Handled Writing, reviewing and development of MW SOPs for CSR, protocol writing and related forms6. Managed timely deliverables after appropriate review/Quality Control (QC) to maintain quality for all documents as per Service Level Agreements (SLAs) and Key Performance Indicators (KPIs), Turnaround Time (TAT) and productivity set as per internal/client specifications7. Lead and Supervise the day-to-day activities of the team, identify the training needs of the team members and provide them guidance and support.

Durham, North Carolina, Us

Started my career from Global Clinical trial operation. and promoted to MW in one year. My job description involves preparation, review and QC of Final Draft Clinical Study Report (Phase II, III), SAE Narratives, Study Protocols amendments, Investigator Brochure updates, Paper Publications [Abstracts, review articles], and PIS/ICF forms in line with ICH 3 using both Chiltern and Client Template. I handled most critical documents in TA like oncology, Vaccines, Cardiology and RA. In addition I also handled writing, review and development of MW SOPs for CSR, protocol writing and related forms.

Mumbai, Maharashtra, In

Clinical Research Operations and Regulatory and Medical WritingManaging, monitoring of investigating sites to ensure all the clinical trial activities conform to the protocolDevelop monitoring guidelines prior to study initiation and conduct CRA trainingCoordinate and perform comprehensive site management on one or more clinical protocols; conduct and document pre-study, initiation, interim and closeout site visitsdisseminate information to site staff regarding study protocol, CRFs and FDA/ICH GCP guidelinesMonitor study protocols, including review of source documents, case report forms, regulatory documents, informed consents, investigational product, clinical supply accountability, AE/SAE reporting, and transmittal of CRFsEnsure immediate reporting of any serious adverse events IRB/ethics committee submissions: Preparation and maintenance of drug/biologic master file

Lexington, Ky, Us

Executive Management In Healthcare (One Year Full Time Residential Program), Health/Health Care Administration/Management

Doctor Of Philosophy (Ph.D.), Applied Biology (Medical Sciences)

Master Of Science (Msc), Clinical Laboratory Science/Medical Technology/Technologist