Sobia Maqsood
Lawrenceville,NJ
Summary
Focused, passionate, hardworking Public Health professional with over 8 years of extensive experience in Drug Safety and Clinical Research. Proficient in high pressure, deadline oriented atmosphere with the ability to resolve issues.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
ZN Healthcare
03.2021 - 06.2023
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Followed informed consent processes and maintained records
- Maintained compliance with protocols covering patient care and clinical trial operations
- Coordinated project team meetings and trained new staff on protocols
Drug Safety Specialist
United BioSource Corp. (via Mindlance Staffing)
09.2020 - 02.2021
- Responsible for Book-in, duplicate check and accurate full Data Entry of safety case reports into safety database ARGUS
- Assisted in timely and accurate completion of reconciliation activities
- Assisted in sending and tracking follow-up queries for safety case reports in timely manner
- Ensured timely submissions of SAEs/AEs to Regulatory Authorities and external partners/collaborators as required by Pharmacovigilance Agreements
- Drafted reports of safety findings and prepared presentations for management
- Ensured filing of safety case reports and other project-related documents, as required
- Assisted in timely identification of Safety Reports and/or relevant safety information during monitoring of literature review
Drug Safety Data Management Specialist
Pfizer Inc.
04.2013 - 09.2018
- Processed Individual Case Safety Reports (ICSRs) including triage and data entry in electronic database ARGUS
- Processed and conducted quality assurances and quality control of Clinical Trial, Post Marketing and literature cases
- Created comprehensive narratives from source documents and issued written queries to obtain follow-up information
- Proactively provided case processing activities to ensure high-quality individual case safety reports of adverse events
- Assigned and completed expedited cases to ensure regulatory and internal compliance
- Managed and maintained Global Operations Drug Safety mailbox
- Maintained oversight of vendor activities including routine review of cases, reconciliation, and compliance meetings
- Reviewed and approved Change Controls, Safety Management Plans, PV Agreements and other guidance documents
- Respond to inquiries from healthcare professionals and business partners regarding clinical trials and AE information
- Supported Pharmacovigilance Audits and Inspections
- Informed appropriate staff of delayed, missing or incomplete items; established follow-up procedures and completed all transactions in a timely manner
- Developed and maintained Drug Safety standard operating procedures (SOPs), job aid and work instructions
- Performed Regulatory and business partner AE/SAE submissions including E2B, Assessed and Non-Assessed exchange in accordance with PV agreements
- Supported coordination activities for Safety Management Team meetings including preparation of agenda, presentations and recording minutes
- Acted as Safety Database (ARGUS) administrator working with the team to execute system upgrades and safety reports
- Trained and mentored new drug safety associates while providing supervision and teaching key skills in Drug Safety
Drug Safety Associate
Pfizer Inc. (via Axelon Staffing)
07.2012 - 04.2013
- Responsible for completion of case information and quality review to ensure accuracy and completeness
- Triaged of incoming cases to prioritize daily workflow management
- Reviewed source documents for consistency, verification of adverse event data and case validation
- Evaluated cases for seriousness, relatedness and expectedness according study guidelines
- Performed comprehensive case data entry and narrative writing according to standard operating procedures
- Performed Medical coding using MedDRA and WHO Drug Dictionary in accordance with ICH GCP guidelines
- Provided follow-up on adverse event cases by preparing, sending out and tracking queries to reporters
- Accepted E2B cases received through Argus Electronic Submissions Module (ESM) from EU Health Authorities
- Participated in SAE reconciliation between Safety and Clinical databases
- Reviewed and updated follow-up letters
- Participate in internal and external team meetings and project specific training sessions.
- Communicated with internal or external contacts to resolve issues related to case processing.
Health and Safety Inspector, Intern
Edison Department of Health and Human Services
05.2011 - 09.2011
- Performed county and state inspections and completed inspection reports of restaurants and recreational areas
- Maintained and updated all food facility permit and license records to ensure accuracy and currency
- Monitored and addressed all complaints by public to ensure appropriate action is taken
- Worked closely with Center for Disease Control (CDC) on epidemic outbreak of ongoing investigations
- Assisted with preparation and execution of presentations, strategies, and safety programs
- Participated in workshops and presentations related to projects to gain knowledge
Education
Master of Public Health - Epidemiology
University of Texas Health Science Center
Houston, TX12.2022
Bachelor of Science - Public Health
Rutgers State University of New Jersey
New Brunswick, NJ05.2011
Certification
Good Clinical Practice (GCP) July, 2023
Federal Emergency Management Agency (FEMA) May, 2022
Timeline
Clinical Research Coordinator
ZN Healthcare
03.2021 - 06.2023
Drug Safety Specialist
United BioSource Corp. (via Mindlance Staffing)
09.2020 - 02.2021
Drug Safety Data Management Specialist
Pfizer Inc.
04.2013 - 09.2018
Drug Safety Associate
Pfizer Inc. (via Axelon Staffing)
07.2012 - 04.2013
Health and Safety Inspector, Intern
Edison Department of Health and Human Services
05.2011 - 09.2011
Master of Public Health - Epidemiology
University of Texas Health Science Center
Bachelor of Science - Public Health
Rutgers State University of New Jersey
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