Smita Patel
Wayne
Summary
Registered nurse with extensive clinical expertise in cardiovascular and emergency medicine, complemented by a strong background in global pharmacovigilance. Demonstrates effective leadership in clinical study oversight, regulatory compliance, and safety management, contributing to enhanced patient safety and project success.
Overview
1
1
Certificate
25
25
years of professional experience
Work History
MANAGER, GLOBAL SAFETY OPERATIONS
Novavax
Gaithersburg
04.2022 - Current
- Lead and co-lead oversight on clinical study projects covering phase II to phase III
- Execute comprehensive review and regulatory evaluation of SAE/AESI reports obtained from investigation sites.
- Oversight of CROs performing pre-market and post-market safety activities
- Monitor cases processed by CROs or in-house to completion to ensure adherence with established case processing timelines and initiate urgent follow-up to CROs or investigative sites to retrieve missing information, according to AE/SAE reporting requirements, regulatory guidelines, and department SOPs.
- Maintain open communication with internal cross-functional leadership and with CROs/Vendors and Investigational sites.
- Actively participate in the development and implementation of Safety Management Plans for study-specific workflow.
- Perform reconciliation of safety data with collaborating Business Partners.
- Train teams and CROs in new clinical safety database (LifeSphere Multivigilance-LSMV) as Subject Matter Expert
- Performed training on SAE reporting and specific data entry conventions to sites and CROs to maintain high level of quality.
- Document non-compliance with client’s regulatory requirements in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required.
- Developed and managed SOPs, Work Instructions, and Templates
- Worked with Global Vaccine Safety Compliance to maintain inspection readiness and act as subject matter expert during inspections/audits and supported client audits and regulatory inspections from a pharmacovigilance operations standpoint.
- Participate in internal and cross-functional meetings including Clinical Operations, Data Management, and other departments within the company and with vendors.
- Drafting and updating Safety Management Plans describing the responsibilities specific to the management of safety data between the Sponsor and the Vendor regarding case processing as it relates to specific study protocols.
- Drafting and updating of Appendices associated to the Safety Management Plans which incorporate but are not limited to study-specific narrative templates, contact lists, SAE/Pregnancy forms, reporting requirements, IB tracking.
- Create study specific SAE and Pregnancy forms to distribute to sites for reporting.
- Provide the business requirements to the team responsible for UBC Argus implementation and maintenance. In conjunction with the Argus team, participate in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.
- Oversight QC of eTMF filing
SAFETY SCIENTIST-PHARMACOVIGILANCE
United Biosource Corporation
11.2017 - 04.2022
- Function as a team lead for post marketing and clinical trial projects: Oversight of case processing activities/workflow, submissions, distribution and queries status, communications with client/Investigator sites, team training, liaison between the team and client, mentorship to new staff.
- Assist with the preparation of adverse event reporting plans (AERPs), expedited reporting plans (ERPs), DECs and other plans as required for clinical trials and post marketing.
- Perform review and regulatory assessment of adverse event reports received from investigation sites.
- Participate in preparing Periodic Adverse Drug Experience Report (PADER) and Development Safety Update Report (DSUR)
- Involved in User Acceptance Testing of new version of ARISg and Argus safety database prior to production.
- Experience in ARISg and Argus Safety Database including case processing activities, database listings for reconciliations, review of case line listings.
- Training new team members regarding databases and specific data entry conventions
- Process and evaluate SAE reports for global clinical trials and AE and SAE reports for post marketing according to the customer’s standard operating procedures (SOPs)
- Reviewed/processed Serious Adverse Events: reviewed tracking tool for accuracy/quality.
- Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to individual case study reports (ICSRs), aggregate data, database line listings.
- Assist in the reconciliation of clinical and safety databases.
- Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports.
- Liaise with both internal and external vendors (clients, patients, and HCPs)
- Monitor compliance metrics and ensure appropriate documentation when deficient.
- Liaise with investigational sites regarding safety issues; served as medical resource for investigational sites and personnel on safety related issues.
- Liaised with Medical Monitor, Project Manager, and other departments for project issues (listing reviews, quality assurance)
- Prepared/implemented Study Specific Procedures
- Experience in coding using MedDRA and WHO Drug
REGISTERED NURSE- Emergency Department
Einstein Montgomery Medical Center
10.2012 - 10.2017
- Responsible for total patient care 4:1/5:1 nurse-patient ratio including primary assessment, triage, medication administration, diagnostic studies diagnostic studies, cardiac monitoring, care plans, direct care.
- Chart documentation under Aesis (CERNER)
- Created, maintained, and managed staff scheduling for RNs, Unit Clerks and ED technicians for 28-bed unit.
- Participant in Unit Council; responsible for maintaining unit guidelines, education materials, infection control, communication boards and assistance co-workers in maintaining compliance with up-to-date materials.
- Charge nurse role, interview candidates for positions (such as manager, staff registered nurse, and technicians).
SAFETY SURVEILLANCE MONITOR
Sentrx
10.2012 - 07.2013
- Case processing non-serious and serious adverse events according to client specifications while ensuring regulatory compliance and completion of expedited cases to ensure regulatory and client deadlines are met.
- Ensure specific project standards, regarding timelines and data quality.
- Review initial and follow-up pharmacovigilance transactions from consumers, health care professionals, attorneys, or investigators, as necessary, in accordance with Sentrx policy and procedures.
- Perform triage of cases prior to case processing.
- Ensure and maintain quality of data according to medical review and client revisions.
- Assist in running ad hoc reports from the client safety database to support client or regulatory health authority queries.
- Maintain knowledge through up-to-date training and SOPs, both Sentrx and client specific.
- Coordinate with team on preparation of Periodic Reports/PSURs/DSURs and data lock dates.
- Provide the business requirements with the team responsible for UBC Argus implementation and maintenance. In conjunction with the Argus team, participates in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.
SENIOR DRUG SAFETY SURVEILLANCE
Pfizer Pharmaceuticals
11.2010 - 06.2012
- Review, analysis, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
- Apply E2B knowledge and expertise to accept, assess, verify, code, and review adverse event (AE) cases received electronically in E2B format.
- Split and merge cases by analyzing cases for specific criteria and cross-referencing split AE cases.
- Assess, process, and appropriately mark expedited reports, determining whether AE cases meet specific criteria and manually scheduling expedited reports as necessary.
- Review, rank, verify, process, and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeling); special scenarios; product complaint information; medical device adverse events; reportability with due date; and accuracy and consistency.
- Based on assessment of AE cases, process accordingly.
- Apply judgment and expertise to accurately label events, to determine whether causality is medically confirmed, and to analyze case criteria to determine the appropriate workflow for case processing.
- Write and edit case narratives.
- Quality review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
- Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
- Create power point presentations for training purposes.
- Train vendors and other company site location on therapeutic area products for knowledge transfer.
SAFETY SURVEILLANCE ASSOCIATE
Smith Hanley Consulting for Wyeth Pharmaceuticals
07.2010 - 11.2010
- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Assess cases to distinguish those with complexities and/or specific issues and escalate appropriately.
- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeling); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
- Quality review case criteria to determine the appropriate workflow for case processing.
- Write and edit the case narrative.
DRUG SAFETY SPECIALIST II
Aerotek, Inc. for Johnson & Johnson, Benefit Risk Management
01.2010 - 07.2010
- Processed and reviewed serious and non-serious adverse event reports, ensuring accurate narrative writing and quality assessment for initial and follow-up reports received from consumers via multiple channels.
- Review and process transcribed calls from the consumer call center for processing adverse events.
- Reviewed adverse event information to assess required actions per internal policies, identifying critical follow-ups and coordinating medical assessments for Quality Assurance submissions.
- Followed up with healthcare professionals and consumers to gather essential information for report completion, enhancing data integrity.
- Perform MedDRA and WHO dictionary coding using in-depth knowledge of medical terminology.
LEAD CLINICAL SAFETY OFFICER (for Sanofi-Aventis Pharmaceuticals)
Smith Hanley Consulting Group
05.2007 - 03.2009
- Reviewed and distributed Serious Adverse Event (SAE) data and medical documents, ensured FDA compliance.
- Educated and trained investigational sites and clinical team on proper SAE reporting.
- Train, mentor and supervise Clinical Safety Officers protocols, processes, and databases.
- Tracked and reconciled SAEs, reviewed completed SAE reports for local site files and archiving.
- Liaison and point of contact between Global Pharmacovigilance & Epidemiology, Medical Advisor, clinical team, and Investigator/Study Coordinators.
- Communication of safety issues to sites and site-designated regional clinical research associates.
- Phase III, randomized, double-blinded evaluation study of cardiovascular endpoints and primary/secondary outcomes.
- Generate and deliver in-house presentations.
- Responsible for CRF review.
Drug Safety Associate, Phase IV, Open-label; Rescue study for a topical cream for the treatment of Actinic Keratosis, for Graceway Pharmaceuticals, LLC
Research Pharmaceutical Services
08.2004 - 05.2007
- Developing a safety plan and ensuring a seamless transition during the change of sponsors.
- Primary contact responsible for maintaining and reporting up-to-date project specific drug safety data.
- Summarize source documentation and prepare collective narrative for SAE reporting within 24-hours of notification.
- Responsible for reviewing case report forms (CRF) and discrepancies for coding and CDM assistance.
- Use of Clintrial/Clintrace database for SAE reconciliation and quality review of adverse event terms and concomitant medications.
Subject Medical Writer, Phase II and Phase III studies, for Otsuka Maryland Research Institute (OMRI)
10.2005 - 02.2006
- Develop a comprehensive narrative from data listings and CIOMS reports generated by OMRI.
- Quality review and edit documents prepared by other writers.
- Complete study specific documents and other assigned tasks within established timelines.
- Assist with development of satellite office processes and procedures.
Pharmacovigilance Associate for JJPRD, Benefit Risk Management
12.2004 - 10.2005
- Process, coding, narrative generation, quality review of spontaneous and solicited serious and non-serious adverse events for post-marketing.
- Use of SCEPTRE database, a web-based system for adverse event collection and reporting.
- Utilize Medra and WHO to ensure proper reporting and coding.
- Prepare daily performance metrics.
REGISTERED NURSE- Emergency Department
Montgomery Hospital
06.2003 - 10.2005
- Responsible for total patient care 4:1/5:1 nurse-patient ratio including primary assessment, triage, medication administration, diagnostic studies diagnostic studies, cardiac monitoring, care plans, direct care.
- Chart documentation under Aesis (CERNER)
- Created, maintained, and managed staff scheduling for RNs, Unit Clerks and ED technicians for 28-bed unit; review of paid time off requests, holiday scheduling and maintaining staffing level for a safe environment.
- Participant in Unit Council; responsible for maintaining unit guidelines, education materials, communication boards and assisting co-workers in maintaining compliance with up-to-date materials.
- Interview candidates for positions, such as manager, staff registered nurse, and technicians.
CLINICAL RESEARCH SITE COORDINATOR
Clinlogix, LLC
11.2003 - 05.2004
- Responsible for implementing and achieving recruitment strategy for clinical trials.
- Oversee and manage multiple clinical sites, clinical research coordinators and study personnel.
- Execution of clinical protocol tasks, including CRF completion oversight, IP accountability and source document review.
- Interface with Sponsor’s representatives.
- Ensure compliance with study protocol, FDA, CFR and ICH/GCP guidelines.
SAFETY SURVEILLANCE ASSOCIATE, Clinical research for Phase IV, Post-marketing, and Drug Recall
Covance Periapproval Services
08.2001 - 04.2003
- Maintained and reported up-to-date project-specific drug safety information, ensuring compliance and timely communication.
- Summarized data collected for preparing SAE reports within 24-hours of notification.
- Review medical charts on a drug recall in accordance with FDA regulations for legal defense.
- Compiled and submitted comprehensive monthly summaries of adverse events to facilitate informed decision-making.
- Served as primary contact for clients, investigators, and sites, providing timely SAE information and updates to support effective collaboration.
- Develop SAE reporting process for new studies.
- Use of ARISg and Argis databases for SAE data tracking, reconciliation, and quality review.
Education
GRADUATE CURRICULUM - Advanced Practice Nursing
University of Pennsylvania
Philadelphia, PA01-1996
BACHELOR OF SCIENCE - Nursing
Pennsylvania State University
University Park, PA01-1992
Skills
- Interpersonal skills
- Problem solving
- Presentation skills
- Product education
- Argus safety database
- ArisG safety database
- Training and mentoring
- Communication skills
- Computer proficiency
- Microsoft Windows and WordPerfect
- Excel and PowerPoint
- Web-based applications
- Patient care technical skills
- Medication administration
- Intravenous therapy
- Phlebotomy techniques
- Laboratory result interpretation
- Physical, Mental and Emotional assessments
- Wound care management
- Urinary catheter insertion
- Monitoring techniques
- Oxygen administration
- Telemetry interpretation
- Leadership and supervisory skills
- Scientific interpretation skills
- Organizational skills
Certification
- Registered Nurse, Pennsylvania State Board
Timeline
MANAGER, GLOBAL SAFETY OPERATIONS
Novavax
04.2022 - Current
SAFETY SCIENTIST-PHARMACOVIGILANCE
United Biosource Corporation
11.2017 - 04.2022
REGISTERED NURSE- Emergency Department
Einstein Montgomery Medical Center
10.2012 - 10.2017
SAFETY SURVEILLANCE MONITOR
Sentrx
10.2012 - 07.2013
SENIOR DRUG SAFETY SURVEILLANCE
Pfizer Pharmaceuticals
11.2010 - 06.2012
SAFETY SURVEILLANCE ASSOCIATE
Smith Hanley Consulting for Wyeth Pharmaceuticals
07.2010 - 11.2010
DRUG SAFETY SPECIALIST II
Aerotek, Inc. for Johnson & Johnson, Benefit Risk Management
01.2010 - 07.2010
LEAD CLINICAL SAFETY OFFICER (for Sanofi-Aventis Pharmaceuticals)
Smith Hanley Consulting Group
05.2007 - 03.2009
Subject Medical Writer, Phase II and Phase III studies, for Otsuka Maryland Research Institute (OMRI)
10.2005 - 02.2006
Pharmacovigilance Associate for JJPRD, Benefit Risk Management
12.2004 - 10.2005
Drug Safety Associate, Phase IV, Open-label; Rescue study for a topical cream for the treatment of Actinic Keratosis, for Graceway Pharmaceuticals, LLC
Research Pharmaceutical Services
08.2004 - 05.2007
CLINICAL RESEARCH SITE COORDINATOR
Clinlogix, LLC
11.2003 - 05.2004
REGISTERED NURSE- Emergency Department
Montgomery Hospital
06.2003 - 10.2005
SAFETY SURVEILLANCE ASSOCIATE, Clinical research for Phase IV, Post-marketing, and Drug Recall
Covance Periapproval Services
08.2001 - 04.2003
GRADUATE CURRICULUM - Advanced Practice Nursing
University of Pennsylvania
BACHELOR OF SCIENCE - Nursing
Pennsylvania State University
Expertises
- Great interpersonal skills in oral and written forms.
- Team-oriented, highly productive, and motivated individual.
- Innovative Problem Solving
- Presentation Skills/Product Education
- ARISg and Argus Safety Database
- Training, Mentoring & Communication
- High proficiency in the use of computers: Windows, WordPerfect/Works, Excel, and PowerPoint, web-based applications.
- Possesses a wide range of patient-care technical skills including but not limited to the following: medication administration, Intravenous therapy, phlebotomy, interpreting laboratory results, physical/mental/emotional assessment, wound care, urinary catheter insertion and monitoring, oxygen administration, telemetry interpretation.
- Leadership and supervisory skills, training, and mentorship experience
- Strong scientific interpretation and organization skills.
- American Heart Association volunteer/lecturer
- ACLS, PALS & BLS certification
Personal Information
Title: RN, BSN
Professional Nursing Experience
- The Judge Group Medical Staffing, AGENCY NURSE, 01/2005, present
- Progressive Nursing Staffers, AGENCY NURSE, 08/2001, 12/2006
- Bryn Mawr Hospital, Emergency Department, REGISTERED NURSE, 08/2001, 05/2003, part-time
- Kennedy Memorial Hospital, Emergency Department, REGISTERED NURSE, 07/1996, 07/1997
- Medical College of Virginia, Cardiovascular Transplant Unit, REGISTERED NURSE, Clinician II, 06/1995, 06/1996
- Hahnemann University Hospital, Telemetry Unit, REGISTERED NURSE, 08/1992, 06/1995
Professional Overview
I am a diversely experienced registered nurse with a strong clinical background in cardiovascular and emergency medicine, complemented by global pharmacovigilance experience focused on clinical trials and international regulatory requirements. I excel in clear communication, team leadership, analytical decision-making, and efficient problem-solving in fast-paced environments.
Awards And Professional Development
- Individual Performance Awards for Safety Data Migration
- Training/Product Knowledge Transfer
- Mentorship
Expertises
- Great interpersonal skills in oral and written forms.
- Team-oriented, highly productive, and motivated individual.
- Innovative Problem Solving
- Presentation Skills/Product Education
- ARISg and Argus Safety Database
- Training, Mentoring & Communication
- High proficiency in the use of computers: Windows, WordPerfect/Works, Excel, and PowerPoint, web-based applications.
- Possesses a wide range of patient-care technical skills including but not limited to the following: medication administration, Intravenous therapy, phlebotomy, interpreting laboratory results, physical/mental/emotional assessment, wound care, urinary catheter insertion and monitoring, oxygen administration, telemetry interpretation.
- Leadership and supervisory skills, training, and mentorship experience
- Strong scientific interpretation and organization skills.
- American Heart Association volunteer/lecturer
- ACLS, PALS & BLS certification
Personal Information
Title: RN, BSN
Professional Nursing Experience
- The Judge Group Medical Staffing, AGENCY NURSE, 01/2005, present
- Progressive Nursing Staffers, AGENCY NURSE, 08/2001, 12/2006
- Bryn Mawr Hospital, Emergency Department, REGISTERED NURSE, 08/2001, 05/2003, part-time
- Kennedy Memorial Hospital, Emergency Department, REGISTERED NURSE, 07/1996, 07/1997
- Medical College of Virginia, Cardiovascular Transplant Unit, REGISTERED NURSE, Clinician II, 06/1995, 06/1996
- Hahnemann University Hospital, Telemetry Unit, REGISTERED NURSE, 08/1992, 06/1995
Professional Overview
I am a diversely experienced registered nurse with a strong clinical background in cardiovascular and emergency medicine, complemented by global pharmacovigilance experience focused on clinical trials and international regulatory requirements. I excel in clear communication, team leadership, analytical decision-making, and efficient problem-solving in fast-paced environments.