Niravkumar Patel
Regulatory affair and Pharmacovigilance
New Jersey,NJ
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Summary
PHARMACOVIGILANCE SPECIALIST SAFETY REPORTING | SCIENTIFIC WRITING | DRUG SAFETY SCIENCE OBJECTIVE Registered pharmacist (License #28RI04225000) with a Masters’ degree in Regulatory Affairs Sciences, background in safety reporting, drug development, project management, and a keen interest in pharmacovigilance. Self-directed professional who is equipped with a strong ability to conduct thorough research, ensure quality, and independently execute high quality deliverables in a timely manner even when given ambiguous direction. Fast learner, innovative thinker, and a team player who can adapt and support overall company goals. Excellent interpersonal and communication skills and works effectively in collaborative, cross-functional team dynamics. Eager to transition and take the years of experience and translatable skillsets as a pharmacist, drug safety, regulatory affairs, and research professional, into a drug safety role.
Overview
9
9
years of professional experience
Work History
06.2019
- Solid Lipid Nanoparticles, Annual Meeting - Pharmacy Council of India,
- Conducted literature search for Sonidegib - APPERotation Medical Affairs May 2020
- Presentation on Methotrexate toxicity in CNS lymphoma Patients – IPPEHospital Jan 2021
- Presentation on Methotrexate toxicity in CNS lymphoma Patients – IPPEHospital Jan 2021
Pharmacovigilance and Regulatory Affair Associate
Avet Pharmaceuticals Inc
01.2022 - Current
- Prioritized project-related tasks to efficiently complete essential tasks.
- Performed and documented quality control checks to maintain compliance with company initiatives. Conducted audit of third party pharmacovigilance provider.
- Developed or tracked quality metrics.
- Wrote or updated standard operating procedures, work instructions for pharmacovigilance. Wrote safety data exchange agreements with other business partner.
- Prepared and submitted regulatory file applications and supporting documentation such as CBE-30, CBE-0, PAS, annual reports, draft labels.
- Received, researched and resolved consumer inquiries.
- Maintained and archived regulatory paperwork.
- Prepared and maintained document inventory for core dossier preparation.
- Recommended improvements to processes. Wrote pharmacovigilance training presentation for new hire. Conducted monthly and quarterly reconciliation activities to ensure accuracy of safety data exchanged between business partner.
- Assisted with regulatory product compliance initiatives such as assessment of change control in excipient, active ingredients, manufacturing record, packaging record.
- Reviewed PADER data to assess compliance with FDA regulations.
- Provided pre-, ongoing, and post-inspection follow-up assistance support during FDA inspection.
- Reviewed labels for accuracy before submission to FDA.
- conducted pharmacovigilance training for new employees.
- eCTD publication of documents for submission.
- Handled medical inquires, product inquires and product quality complaints.
Associate Intern
Shine Software Solution
05.2020 - 11.2021
- Performed and led quality review of safety reports and utilized ARGUS to search database, prevent duplicate reports, and allow successful quality control for audit trails
- Utilized scientific background knowledge to provide medical judgment for adverse events and triaged new occurrences
- Utilized MEDDRA, WHODD, and CPDfor verifying and confirming coding
- Responsible for in-depth, concise, accurate, chronological and well-written scientific adverse event narrative reports within the documentation management system based on information provided both on standard forms and from medical records and other documents related to the disease /medication
- Responsible for REMS coordination activities as well as escalating urgent SUSARcases to the pharmacovigilance lead
- Collaborated cross functionally with other functional areas to finalize and submit reports
- Provide input /review of relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Perform other activities as identified and requested by management
- Perform case processing clinical and diagnostic data under supervision including medical coding.
Ambulatory Care Extern
Overlook Center
02.2021 - 03.2021
- Acquired skills spanning across multiple rotational experiences as listed above translatable into drug safety
- Utilized background in research and development to implement complex literature research to improve the management of chronic diseases, optimize clinical research strategies, and execute high quality deliverables
- Developed a strong background in Oncology /HIV/clinical guidelines, PK/PDunderstanding, and adverse event reporting
- Utilized primary, secondary, and tertiary research skills to determine optimum regimen choices
- Led multiple research projects and deliverables centered around clinical /efficacy treatment plans, clinical trial design overviews, drug safety narratives, and adverse drug reaction management
- Responded to drug information inquiries to develop patient case narratives, response letters, and informational materials based on literature research, manufacturer trial data interpretation, and therapeutic area expertise
- Led and executed multiple writing projects centered on synthesizing research using evidence-based medicine
- Developed understanding of drug development process, clinical trial design process, and FDAregulations
- Developed a strong understanding of protocol design including effective pharmacovigilance software tools (ARGUS)
01.2020 - 12.2020
Regulatory Affairs Intern
BDPharmaceuticals
09.2020 - 10.2020
- Discussed the impact of change in regulation in EUMDR2017 regulatory guidelines for medical devices on the company's existing and future products
- Developed a strong understanding of regulatory related compliance /understanding for medical devices
- Developed strategies for post marketing follow-up of company’s products to comply with government regulatory authorities
- Prepared and learned how to submit regulatory deliverables across INDand NDAfor the eCTD.
Medical Affairs Intern
Sun Pharmaceuticals
06.2020 - 07.2020
- Developed a strong understanding of promotional material reviews as well as developing educational materials for internal vendors, external stakeholders, and health care providers (HCPs)
- Designed training materials for new hires, especially on oral chemotherapy drugs
- Worked alongside internal stakeholders and external vendors to identifying criteria for key opinion leaders (KOL) for inclusion and segmentation across all external customers that will be instrumental in future clinical studies, marketing initiatives, and publication planning
- Analyzed field studies and reports, compiled information, and submitted concise and informative summaries.
Pharmacy Business Intern
Pharmacy
05.2020 - 06.2020
CVS Pharmacy
05.2020 - 06.2020
Pharmacy Business Intern, Extern
CVS Pharmacy, Acute Care Rotation, Ocean
05.2020 - 06.2020
Clinical Pharmacy Rotation Intern, Pharmacy Technician
Healthcare, Research Facilities, Oaktree Pharmacy
09.2014 - 06.2020
- Worked as an intern for several clinical /pharmacy rotations requiring in depth clinical knowledge and requiring skillsets that are transferable as a pharmacovigilance scientist in the state as listed below: o
Regulatory Affairs Associate Intern
Rocket Pharmaceuticals
04.2019 - 04.2020
- Prepared, led, and executed regulatory related strategy development plans alongside the regulatory lead and other functional areas (clinical development, statistics, Regulatory Operations)
- Understood how to draft, review, and coordinate submission of strategic submissions including Orphan Drug
- Designation Applications, Pediatric Study Plans (PSP) Pediatric Investigational Plans (PIP)
- Led and assisted with the preparation of an ANDAsubmission by preparing documents of various complexities within the eCTDfor submission
- Niravkumar Patel, PharmD, RPh Page 2
- Developed strong understanding of Module 1, 2, 3, 4, and 5 related submissions including DSURs, Investigational
- Brochures, Meeting Requests, Briefing Books, protocol submissions /Amendments, and Clinical Study Reports (CSR).
Pharmacy Business Intern
CVS
05.2019 - 06.2019
Hospital Pharmacy Intern
05.2018 - 06.2018
Pharmacy Intern
Walgreens Pharmacy
09.2014 - 03.2017
Education
Doctor of Pharmacy -
Master - regulatory affair science
Skills
- KEYCOMPETENCIES
- Safety Narrative Writing Cover Letters, Form 1571, 356h Drafting Project Management
- IND / NDA Maintenance Submissions eCTD Modules 1,2,3,4,5 Submissions ICH Guidelines, GCP
- Code of Federal Regulations (CFR 21 Part 11) Annual Reports (PADER/PSUR/DSUR) Adaptable / Goal Driven
- Cross-Functional Collaboration Regulatory Affairs Strategy / Compliance Argus – Oracle
- Drug Development Knowledge Complex Literature Evaluation Microsoft Office Skills
- TECHNICALSKILLS
- Microsoft Office ( Word, PowerPoint, OneNote, Outlook, Teams, Publisher, Access, SharePoint) Adobe Acrobat Data
- Analysis Document Management ARGUS Safety Narrative Writing Communication Skills
- Strategic Analysis
- Data Evaluation
- Team Collaboration
- Workflow Optimization
- Quality Control
- Multitasking and Organization
- Microsoft Excel
- Microsoft Power BI
- Microsoft Office Suite
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Pharmacovigilance and Regulatory Affair Associate - Avet Pharmaceuticals Inc
01.2022 - Current
Ambulatory Care Extern - Overlook Center
02.2021 - 03.2021
Regulatory Affairs Intern - BDPharmaceuticals
09.2020 - 10.2020
Medical Affairs Intern - Sun Pharmaceuticals
06.2020 - 07.2020
Associate Intern - Shine Software Solution
05.2020 - 11.2021
Pharmacy Business Intern - Pharmacy
05.2020 - 06.2020
- CVS Pharmacy
05.2020 - 06.2020
Pharmacy Business Intern, Extern - CVS Pharmacy, Acute Care Rotation, Ocean
05.2020 - 06.2020
-
01.2020 - 12.2020
-
06.2019
Pharmacy Business Intern - CVS
05.2019 - 06.2019
Regulatory Affairs Associate Intern - Rocket Pharmaceuticals
04.2019 - 04.2020
Hospital Pharmacy Intern -
05.2018 - 06.2018
Clinical Pharmacy Rotation Intern, Pharmacy Technician - Healthcare, Research Facilities, Oaktree Pharmacy
09.2014 - 06.2020
Pharmacy Intern - Walgreens Pharmacy
09.2014 - 03.2017
Fairleigh Dickinson University - Doctor of Pharmacy,
Fairleigh Dickinson University - Master, regulatory affair science
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