Dr. Ujwala Salvi Email and Phone Number
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An Accomplished Executive with proven leadership skills, strong business acumen, and a deep understanding of the Global Pharmaceutical R & D, Clinical Research Operations, Pharmacovigilance & Regulatory Writing for Pharma, Medical Devices and Biosimilar industry.I am recognized for driving positive change, delivering solutions, and nurturing strong relationships in the Pharmaceutical /CRO industry.I am a well known speaker and already involved in many leadership orations across various platforms like World-wide CPHI, World Drug Safety, DIA and World Economic forum. For Global Clinical Trial Operations, I have worked closely in various therapeutics areas, have seen the Clinical Development Closely in Respiratory, Derma, Vaccines, Ophthalmology and Oncology. End to end Global Pharmacovigilance is handled for more than 8 plus yrs in an Entrepreneurship with Nucleon Therapeutics. In my Entrepreneurship journey over 5 years with Nucleon Therapeutics, a Mumbai based CRO, I single-handedly led Global Business development, and day to day Operations in various service areas. At Nucleon, we have well defined, GVP compliant Pharmacovigilance systems & SOP driven procedures in place and has an track records successful regulatory inspections from USFDA. In addition, we have successfully passed several Vendor Qualifications from our customers across India and North America.To support our Pharmacovigilance, we have established Cloud based GDPR compliant Medical Information Call Center (MICC) to receive the ADR & Product complaint.
Nucleon Research Pvt. Ltd
View- Website:
- nucleon.co.in
- Employees:
- 13
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Nucleon Research Pvt. LtdBuffalo, Ny, Us
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Founder, Ceo & Head Of Clinical OperationsNucleon Research Pvt. Ltd May 2017 - PresentMumbai, Mh, InNucleon 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.
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Head Of Clinical Operations, Regulatory Affairs & Business Development At Catawba Research, LlcCatawba Research, Llc Feb 2020 - Jan 2023Charlotte, Nc, UsI 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. -
Professor/Senior Faculty In Clinical Research And PharmacovigilanceIes'S Management College And Research Centre (Iesmcrc) Jun 2018 - Jul 2022Mumbai, Maharashtra, InPrime 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. -
Head Of Business Development & Sales - ApacNextrove, Llc Jan 2019 - Sep 2020Princeton, New Jersey, UsEnd 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 -
Independent Non-Executive Board Of DirectorSudarshan Pharma Industries Private Limited Mar 2019 - Jan 2020
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Pre-Sales & Business DevelopmentTata Consultancy Services May 2016 - Dec 2016Mumbai, Maharashtra, InSupport 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 -
Senior Business Development ConsultantCadila Pharmaceuticals Limited Jan 2016 - May 2016Ahmedabad, Gujarat, InFull 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 -
Management Consultant Pharma R & DTorrent Pharmaceuticals Ltd Jun 2015 - Dec 2015Ahmedabad, Gujarat, In -
Associate Director- Business Development, And Quality AssuranceMedical Devices Dec 2013 - Dec 2014Business 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
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Associate Medical WriterCognizant 2010 - 2013Teaneck, New Jersey, Us1. 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. -
Regulatory And Medical WriterChiltern International Pvt Ltd, Mumbai Sep 2008 - Nov 2010Durham, North Carolina, UsStarted 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. -
Clinical Research AssociateMacleods Pharmaceuticals Ltd. May 2006 - Aug 2008Mumbai, Maharashtra, InClinical 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 -
Clinical Research AssociatePiramal Pharma Solutions May 2003 - Apr 2006Lexington, Ky, Us
Dr. Ujwala Salvi Skills
Dr. Ujwala Salvi Education Details
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Indian Institute Of Management, CalcuttaHealth/Health Care Administration/Management -
Bombay Hospital College Of Nursing, Bombay Hospital Trust, MumbaiApplied Biology (Medical Sciences)
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University Of MumbaiClinical Laboratory Science/Medical Technology/Technologist
Frequently Asked Questions about Dr. Ujwala Salvi
What company does Dr. Ujwala Salvi work for?
Dr. Ujwala Salvi works for Nucleon Research Pvt. Ltd
What is Dr. Ujwala Salvi's role at the current company?
Dr. Ujwala Salvi's current role is Founder & CEO I BioPharmaceuticals I Vaccine Clinical Development I Clinical Project Management/ Regulatory Submissions I Site Monitoring I Business Development I.
What is Dr. Ujwala Salvi's email address?
Dr. Ujwala Salvi's email address is us****@****rch.com
What is Dr. Ujwala Salvi's direct phone number?
Dr. Ujwala Salvi's direct phone number is +91 2718 22*****
What schools did Dr. Ujwala Salvi attend?
Dr. Ujwala Salvi attended Indian Institute Of Management, Calcutta, Bombay Hospital College Of Nursing, Bombay Hospital Trust, Mumbai, University Of Mumbai.
What are some of Dr. Ujwala Salvi's interests?
Dr. Ujwala Salvi has interest in Dslr Photography, Cooking.
What skills is Dr. Ujwala Salvi known for?
Dr. Ujwala Salvi has skills like Project Management, Strategic Planning, Business Strategy, Market Research, Process Improvement, Medical Devices, R&d, Supply Chain Management, Medical Writing, Clinical Research Operations, Ich Gcp, Quality Assurance.
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