Nikki Patel
@nikkipatel
I support drug safety, pharmacovigilance, and regulatory submissions across FDA-regulated pharmaceutical products.
United StatesWhat I'm looking for
At Parexel International, I support drug safety activities including SAE and PCAE reconciliation, benefit-risk evaluation, signal detection, follow-up safety queries, and global adverse-event reporting compliance. Previously at GlaxoSmithKline Consumer Health, I processed ICSR cases, supported E2B and CIOMS submissions, resolved submission rejections, and contributed regulatory support for Advil Dual Action.
I'm a Pharm.D. with clinical research and pharmacy experience spanning regulatory affairs, quality assurance, clinical pharmacy, and community pharmacy. I've prepared SOPs and manufacturing records, supported FDA-related documentation, and worked with FDA, NDA, ANDA, ICH-GCP, GMP, GLP, and pharmacovigilance requirements.
Experience
Work history, roles, and key accomplishments
Trained in performing serious adverse events (SAE) reconciliation and product compliant adverse event (PCAE) reconciliation. Conducted follow-up queries with healthcare professionals and consumers regarding safety data.
Clinical Pharmacist
Transaction Data Systems
Sep 2020 - Dec 2021 (1 year 3 months)
Provided telephonic outreach to patients to optimize medication use and improve health outcomes. Completed comprehensive medication reviews and communicated with patients and providers.
Staff Pharmacist
PharmCoRx Pharmacy
Mar 2021 - Sep 2021 (6 months)
Monitored drug therapies, advised interventions, and informed customers of potential side effects. Compounded and dispensed medications as prescribed by physicians.
Pharmacist Floater
CVS
Sep 2020 - Mar 2021 (6 months)
Led pharmacy technician support staff in high volume areas to improve metrics. Ensured proper compounding, dispensing, and verification of medications within regulatory guidelines.
Pharmacy Intern
CVS
Sep 2017 - Aug 2020 (2 years 11 months)
Assisted in pharmacy operations and gained practical experience in medication dispensing and patient care.
Processed ICSR cases and reviewed adverse events for submission through E2B and CIOMS to regulatory agencies. Prepared and reviewed development safety update reports and regulatory documents.
Regulatory Affairs Associate
Amnel Pharmaceutical
May 2018 - Aug 2018 (3 months)
Acquired working knowledge of USFDA guidelines, USP chapters, and ANDA filing procedures. Completed projects on drug shortage reporting and regulatory requirements for complex products.
Pharmacy Technician
CVS
Sep 2013 - Aug 2017 (3 years 11 months)
Supported pharmacists in dispensing medications and managing inventory. Provided customer service and assisted with prescription processing.
Quality Assurance Officer
Vital Formulation Itd
Jan 2011 - Apr 2013 (2 years 3 months)
Prepared SOPs for quality assurance, quality control, and production departments. Verified batch manufacturing records and organized records for WHO audits.
Education
Degrees, certifications, and relevant coursework
Nova Southeastern University
Doctor of Pharmacy, Pharmacy
2017 - 2020
Doctor of Pharmacy (Pharm.D.) degree from Nova Southeastern University, Florida, from August 2017 to May 2020.
Gujarat University
Master of Science, Clinical Research
2010 - 2012
Master of Science in Clinical Research from Gujarat University, India, from June 2010 to May 2012.
Nagpur University
Bachelor of Science, Pharmacy
2006 - 2010
Bachelor of Science in Pharmacy from Nagpur University, India, from June 2006 to May 2010.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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