Summary
Overview
Work History
Education
Skills
References
Certification
References
Timeline
Generic

URMI SHAH

Millbury

Summary

Seasoned specialist offering several years of comprehensive experience with Case handling and vendor non-conformance issues. Practiced and knowledgeable professional possessing excellent problem solving and analytical skills paired with strong knowledge of Pharmacovigilance terms, tools and methodologies. Committed to improving overall business processes. Dependable professional with track record of success in field, attention to detail and proactive mindset. Seeks opportunities to improve processes and workflows for team benefit. Conscientious, hardworking and excels at multitasking in fast-paced environments. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

16
16
years of professional experience
1
1
Certification

Work History

Senior Specialist, Global Patient Safety

ASTRAZENECA
06.2024 - Current
  • Led multifaceted pharmacovigilance activities on individual and cross-functional projects, ensuring compliance with global and local guidelines.
  • Managed vendor oversight for ad-hoc case handling inquiries as a Subject Matter Expert in ICSR case handling.
  • Reviewed and enhanced procedures, policies, and systems related to pharmacovigilance components.
  • Conducted comprehensive quality reviews of data, reports, and regulatory submissions, providing detailed analyses to leadership.
  • Developed incident reports within the quality management system to support risk mitigation efforts.
  • Fostered partnerships with internal and external customers to address business unit needs and Patient Safety objectives.
  • Delivered training and mentoring to Patient Safety staff on adverse event reporting and career development.
  • Supported team leadership in executing pharmacovigilance strategies and consulted on Pharmacovigilance Agreements.

Patient Safety Specialist

ASTRAZENECA
12.2022 - 06.2024
  • Serves as a Subject Matter Expert in pharmacovigilance related activities: Case Handling, FDA regulations, ICH/GCP guidelines and EU regulations, medical, scientific and pharmacovigilance operational issues.
  • Provides support for pharmacovigilance outsourcing activities through identification, selection, negotiation, and/or management and maintenance of current Good Pharmacovigilance Practices and required pharmacovigilance activities in assigned projects.
  • Contributes to the scientific and/or technical requirements of new safety-related systems, processes, and procedures within the US region.
  • Contributes to the pharmacovigilance component of contracts/agreements with third parties to ensure quality and integrity of agreement.
  • Provides support to team leadership in implementing various pharmacovigilance strategies.
  • Oversight of follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes.
  • Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA.
  • Lead Patient Safety activities locally/globally for an assigned product(s) and/or project(s) Management and oversight of vendors.
  • Lead the development, refinement and training of Operational processes.
  • Ensure provision of high‐quality outputs from the product‐related or process team to meet regulatory and AstraZeneca requirements.
  • Collaborate with stakeholders to identify local needs within the department and develop innovative strategies to meet business requirements.
  • Trains, mentors, and coaches’ junior members of the team.

Patient Safety Associate

ASTRAZENECA
06.2018 - 11.2022
  • Coordinates and prepares the prompt submission of Investigator Safety Letters to the Clinical ISL Submission group to comply with FDA reporting timelines.
  • Coordinates and prepares the submission of expedited reports, including preparing cross reporting submissions, to the Regulatory Submissions Department to comply with the FDA reporting timeframe.
  • Experience with document management technology and electronic publishing software (e.g. FirstDocs, CARA).
  • Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.
  • Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including expedited and periodic safety reporting.
  • Perform activities required for exchanging safety data with licensing partners to maintain regulatory compliance.
  • Perform reconciliation of adverse event data exchanged with vendors and license partners.
  • Support regulatory inspections and internal audits.
  • Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues.
  • Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers.
  • Supports Safety Surveillance, Safety Systems, Compliance and Marketing Company and Clinical Teams.
  • Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues.

Pharmacovigilance Specialist (Contractor)

MALLINCKRODT
01.2016 - 07.2017
  • Triage incoming adverse event information for completeness, consistency and seriousness which includes medical evaluation and assessment.
  • Review the results of all medical literature searches for any reportable adverse event per FDA requirements.
  • Initiate and coordinate investigations as necessary with Product Monitoring Department.
  • Work in conjunction and effectively communicate with Product Monitoring, Medical Information, Regulatory Affairs (RA), International RA, Clinical Operations, Sales, Legal, Marketing, Quality Assurance and other department personnel.
  • Perform initialization of cases for data entry of initial and follow-up information for global adverse events within the Argus Safety System as well as attachment of electronic source documents to cases.
  • Performed Root-Cause Investigation (RCA) for reports not met compliance and initiating CAPA.
  • Perform medical data entry into the safety database and investigate medical complaints received within the commercial program.
  • Performs data triage of source documentation and confirms valid individual case safety reports (ICSRs).
  • Tracks the status of AE reports, performs electronic submissions and monitors metrics for compliance with ICSR reporting requirements to the global regulatory authorities.
  • Review individual adverse event reports to ensure cases meet Mallinckrodt quality standards before approving for submission to regulatory bodies.
  • Perform adverse event reconciliation activities with vendors, safety partners and/or other groups as deemed necessary.
  • Medical Coding of medical history, concurrent drugs and events using MEDRA and WHO DD.
  • Involved in training and oversight of external partners (vendors) conducting case processing.

Drug Safety Associate

TCS – Bayer
04.2009 - 12.2013
  • Processing serious and non-serious cases using an Argus safety database.
  • Single cases processing in oncology, women’s health care, litigation/lawsuits.
  • Perform risk and quality function on adverse event reports including manual coding as needed using international coding dictionaries – WHODD, MedDRA.
  • Identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources; manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global AE database.
  • Performed Root-Cause Investigation (RCA) for reports not met compliance and initiating CAPA.
  • Evaluates adverse event reports, assesses regulatory status which is seriousness and expectedness/relatedness in order to prioritize workload.
  • Processes adverse event reports from clinical trials and from marketing activities as per company Standard Operating Procedures and guidelines for maintaining regulatory compliance.

Clinical Trial Assistant(Contractor)

QUINTILES
11.2010 - 01.2012
  • Facilitates and coordinates the daily clinical trial activities and playing a critical role in the conduct of the study.
  • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
  • Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
  • Preparing and maintaining clinical trial related documents such as CDA’s, Ethics committee submission, etc.
  • Tracking of Clinical trial related essential and non-essential documents.
  • Maintain project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
  • Completes case report forms. Extracts data from patient charts in a timely manner.
  • Responds to data clarification requests in a timely manner.

Education

MBA - Healthcare Management

American College of Commerce and Technology
Virginia, USA
03.2017

MS - Clinical Research

Institute of Clinical Research
India, India
10.2010

Skills

  • IND Submissions to FDA
  • Pharmacovigilance
  • Regulatory compliance
  • Quality review
  • Vendor management
  • Stakeholder collaboration
  • Problem solving
  • Effective communication
  • Attention to detail
  • Continuous improvement
  • Stakeholder engagement
  • Argus Trainer and User
  • Clinical Trial Study start up
  • Six Sigma Yellow Belt
  • audits and inspection experience
  • Project management
  • Generative AI
  • Flexible and easily approachable
  • Willingness to learn

References

Furnished Upon Request

Certification

  • ICH-GCP
  • Six Sigma Yellow Belt

References

References available upon request.

Timeline

Senior Specialist, Global Patient Safety

ASTRAZENECA
06.2024 - Current

Patient Safety Specialist

ASTRAZENECA
12.2022 - 06.2024

Patient Safety Associate

ASTRAZENECA
06.2018 - 11.2022

Pharmacovigilance Specialist (Contractor)

MALLINCKRODT
01.2016 - 07.2017

Clinical Trial Assistant(Contractor)

QUINTILES
11.2010 - 01.2012

Drug Safety Associate

TCS – Bayer
04.2009 - 12.2013

MBA - Healthcare Management

American College of Commerce and Technology

MS - Clinical Research

Institute of Clinical Research

Similar Profiles

CREATE PROFILE