Pooja Gumudavelli PharmD
Kendall Park,NJ
Summary
As an emerging PharmD, I am eager to embark on a career path that contributes to the vital field of Regulatory Affairs. Throughout my academic journey as well as during clinical experiences, I have cultivated invaluable skills and deepened my understanding of the critical role Regulatory Affairs plays in ensuring the safety and efficacy of pharmaceutical products. Recognizing the importance of ensuring submission quality in accordance with regulatory guidance is imperative in a successful healthcare institution. I am enthusiastic and driven by exploring opportunities where my clinical knowledge can be applied to enhance regulatory processes and uphold the highest standards of patient care. Optimization of care is a value that strongly aligns with me and my goals and I look forward to learning and growing within this role if given the opportunity.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Product Marketing Intern
Upsher Smith Laboratories
05.2021 - 09.2021
- Supported new product launches by increasing product awareness and developing and executing targeted marketing campaigns.
- Conducted market research to identify trends, opportunities, and marketing strategies.
- Monitored and evaluated external market data to help identify opportunities for growth and significant market changes.
- Prepared custom monthly reports for commercial team as well as researched new competitors, and other relevant information to generic portfolio.
- Coordinated company-wide philanthropic project identifying gaps in care within company's generic portfolio.
Pharmacy Intern
Estates Pharmacy
09.2018 - 05.2020
- Utilized advanced pharmacy systems to procure detailed patient and medication information and seamlessly process prescriptions.
- Proficient in compounding, preparing, and administering vaccines and immunizations.
- Calculated dosage, filled prescriptions, and prepared prescription labels with absolute accuracy.
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.
- Developed strong relationships with healthcare providers by effectively communicating about prescription-related matters and collaborating on patient care plans when necessary.
- Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.
- Supported pharmacists during drug utilization reviews, helping identify potential issues and facilitating appropriate interventions.
Intern
Nuclear Diagnostic Products
06.2019 - 08.2019
- Assisted in precise preparation and dispensing of radiopharmaceuticals, ensuring strict adherence to regulations.
- Provided follow-up services to clients and healthcare providers as needed.
- Contributed to medication assays for accurate determination of identity, purity, and strength.
- Recorded and managed data for daily elutions, kit preparations, and inventory, ensuring accuracy.
- Executed quality assurance tests on pharmaceuticals in accordance with established guidelines.
- Pioneered implementation of new, streamlined Standard Operating Procedure review system, enhancing company-wide efficacy.
Regulatory Affairs Intern
Appco Pharma
05.2018 - 09.2018
- Reviewed Prescribing Information Leaflets for text and label comparisons for regulatory submission.
- Familiarized with formulation, review, and approval processes of Batch Records and Batch Packaging Records.
- Researched literature to identify new regulations related to ANDA submissions.
- Familiarized with Orange Book reading and interpretation.
- Supported senior members with Product Specific Guidance and its requirements.
- Enhanced compliance with FDA regulations by contributing to “Controlled Correspondence” and “Pre IND Meeting request compilations."
- Improved efficiency in tracking regulatory changes by implementing comprehensive monitoring system.
- Worked on Module 1 contents of eCTD submission.
Education
Doctor of Pharmacy - PharmD
St. John's University
Jamaica, NY05.2024
High School Diploma -
South Brunswick High School
Monmouth Junction, NJ06.2018
Skills
- Excellent interpersonal and communication skills
- Strong analytical conceptual skills
- Experience with Electronic Medical Record Programs: Epic, Sunrise, CPR
- Knowledge of prescription record reviews and data evaluations
- Proficient in Market Research Analysis, Regulatory Submissions, and GMP knowledge
- Excellent in Document Management, Pharmacotherapy Knowledge, and Patient Education and Counseling
Clinical Externship Experience
- Ambulatory Care Clerkship- Extern
Medicine Specialties at Glen Oaks- Northwell Health (06/2023-07/2023)
- Product Development and Marketing Research- Extern
American Regent (07/2023-08/2023)
- Advanced Community Pharmacy- Extern
CVS Pharmacy (09/2023-10/2023)
- General Inpatient Care- Extern
Nassau University Medical Center (11/2023-12/2023)
- Pediatric Psychopharmacology- Extern
Sagamore Children's Psychiatric Center (1/2024-02/2024)
- Transitions of Care- Extern
St. Francis Hospital (02/2024-03/2024)
- Health Systems and Administration- Extern
Cohen Children's Medical Center at Northwell Health (03/2024-04/2024)
Certification
Intern Permit
Board of Pharmacy, New York Department of Education May 2021
Immunization Intern Permit
Board of Pharmacy, New York Department of Education May 2023
Naloxone Administration Certification
St. John’s University College of Pharmacy August 2022
CPR and Basic Life Support Certification
American Heart Association March 2023
Affiliations
- St. John’s University RAAZ Dance team Queens, NY
- Dance Team Captain 2020-2022
- Treasurer 2020-2022
Research and Publications
Journal Publication: "Managing Hypertension," U.S. Pharmacist, May 2023
Languages
English
Native or Bilingual
Telugu
Native or Bilingual
Timeline
Product Marketing Intern
Upsher Smith Laboratories
05.2021 - 09.2021
Intern
Nuclear Diagnostic Products
06.2019 - 08.2019
Pharmacy Intern
Estates Pharmacy
09.2018 - 05.2020
Regulatory Affairs Intern
Appco Pharma
05.2018 - 09.2018
Doctor of Pharmacy - PharmD
St. John's University
High School Diploma -
South Brunswick High School
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