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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLE Madison, NJ - Street Address
Fully Work Authorized in USA No Visa Sponsorship Required Clinical Quality Assurance Auditor (GCP - CQA) Drug Safety & Pharmacovigilance Associate Professional Summary :Clinical Research Professional with ~7 years of experience in GCP - Clinical Quality Assurance (GCP-CQA) along with Drug Safety & Pharmacovigilance (PV) within both CRO & Pharmaceutical sectors. Skilled in conducting Clinical Study Audits (i.e. Investigator Site Audit, Vendor Audit, Clinical Study / System Documents Review, Trial Master File Review etc.) & performing End-to-End Safety Case Management (from initial AE reporting to resolution). Ensuring regulatory compliance and thus enhancing clinical trial quality processes. I hold a B.Pharm and an M.S. in Clinical Research with strong analytical skills and commitment to excellence in work ethics, clinical research integrity and patient safety. Additionally, my collaborative nature fosters effective teamwork and problem-solving.Core Competencies : Technical Skills :Regulatory Compliance : ICH-GCP E6(R2), USFDA (21 CFR Part 11, 50, 54, 56, 312), GVP, HIPAA.Clinical Research Software : Veeva Vault (QMS, eTMF), Rave EDC, e-Reg, Oracle Argus Safety Database (Version 8.0), MedDra (Version 23.1).Pharmacy Software : Enterprise Rx, Pickpoint Analytical Skills : Risk-Based Auditing, Data Integrity Analysis & Interpretation, Process Improvement, Documentation Review, Risk-Benefit & Causality Assessment, Safety Reporting. Tools : Microsoft (Word, Excel, Powerpoint, Teams, Outlook). Professional Experience :Role : Pharmacy TechnicianClient : Stop & Shop Pharmacy (Part-Time) New Jersey - U.S.A. Jul 2024 to Conti. Assist pharmacists in daily operations, including preparing and dispensing medications to patients. Manage inventory and ensure medications are stocked appropriately. Learned about regulatory requirements and pharmacy practices. Assisted in maintaining clean and organized workspaces. Role : Clinical Quality Assurance Auditor (GCP - CQA) Client : Shionogi Inc. (Contract) New Jersey - U.S.A. Jan. 2024 Jul. 2024 Coordinate, Plan and Conduct clinical study audits - Investigator Site Audit, Vendor Audit, Process Audit, Trial Master File Audit. Reviewed clinical trial documents - Protocols, Case Report Forms (CRF), Informed Consent Forms(ICF), Clinical Lab Reports, Source documents, Clinical Study Report (CSR), Investigator Brochure (IB), Investigator / Trial Master File (ISF/TMF). Identified non-compliance, prepared audit reports with observations - recommendations for CAPA& its follow-up. Reviewed SOPs, Deviation, CAPA, Change Control, Calibration Records, OOS/OOT, Safety logs and maintained QMS tracker. Collaborated and maintained a good working relationship with a QA team and Cross-functional team& Provide training and support to clinical trial staff. Page 1 of 3 Supported sponsor audits / regulatory inspections. Supported Drug safety and Pharmacovigilance activity : Participate in End-to-End safety case management (Case Intake, Case Triage, Data entry of AE, Quality review of AE Reports), Reviewed MedDRA/WHO Drug Coding, Reviewed submitted periodic safety update reports (PSURs/PBRERs), development safety update reports (DSURs), suspected unexpected serious adverse reactions(SUSARs/expedited). Followed regulatory standards - ICH-GCP E6(R2), USFDA (21 CFR Part 11, 50, 54, 56, 312), ICH-E2A, GVP, HIPAA.Role : Sr. Quality Auditor (GCP - CQA); Drug Safety & PV Associate Client : Cliantha Research Gujarat - India Aug. 2019 - Mar. 2023 Conducted risk-based clinical study audits - Investigator Site Audit, Vendor Audit, Process Audit to ensure compliance with regulatory requirements (e.g. ICH-GCP E6(R2), USFDA, CDSCO). Reviewed study documents - Protocols, CRFs, Informed Consent Forms, Clinical Laboratory Reports, Trial Master File, Clinical Study Report Reviewed QMS documents SOPs, Deviation-CAPA, Calibration Reports, OOS/OOT, Safety Logs and maintained QMS tracker. Prepared detailed QA Audit reports with observations/recommendations for CAPA. Trained and mentored junior auditors and clinical staff on quality standards and procedures. Drug Safety and Pharmacovigilance activity : Participate & Review the entire lifecycle of safety cases(from initial AE reporting to resolution).Performed in End-to-End Case Management : Case Intake - Entered full case information on the Argus safety databases and performed duplicate search. Case Triage - Performed based on ICSRs report type (expedited or aggregate), seriousness, causality, expectedness and reporting, prioritize ICSR according to regulatory requirements. Data entry of AE - Reviewed case narratives writing / editing and correcting ICSRs through adverse event reports forms (i.e. CIOMS-II, SUSAR, MEDWATCH, Blue CARD, Yellow Card). Quality review of AE reports - Performed quality review of adverse event reports from clinical trials, post marketing studies, spontaneous cases, regulatory authority, cases processed by other team members.Global Regulatory Compliance : Prepared and Reviewed submitted periodic safety update reports(PSURs/PBRERs), development safety update reports (DSURs), suspected unexpected serious adverse reactions (SUSARs/expedited) and other mandatory safety reports to regulatory authorities.MedDRA/WHO Drug Coding : Performed AE coding using MedDRA and WHO Drug coding systems to ensure accurate and consistent data entry and analysis. Role : Clinical Quality Auditor (GCP-CQA)Client : Sun Pharmaceutical Industry Limited Gujarat - India Mar. 2017 - Aug. 2019 Conducting the clinical study / system audit : Investigator site audit, Process audit, vendor audit. Reviewed Study document : ICF, CRF, TMF, Screening Records, Source documents, Lab Reports. Prepared detailed QA Audit Report with observations and recommendations for corrective and preventive actions (CAPA). Reviewed QMS documents and maintained a tracker - SOPs, Change control, Deviation, CAPA, OOS/OOT, Calibration documents. Assisted in training and mentoring team members on audit procedures and compliance standards, promoting a shared understanding of quality objectives. Role : Sr. Clinical Research Associate (CRA)Client : Cliantha Research Gujarat - India Oct. 2012 - Mar. 2017 Page 2 of 3Therapeutic Experience (Phase I - IV) : Phase-I (BA/BE) : Oncology, Cardiology, Gastroenterology, Neurology, Dermatology. Phase-II / III : Oncology, Infectious Disease. Phase-IV : Adverse Event / Serious Adverse Event Reporting of marketed drug products. Education : M.Sc. Clinical Research + PGDCRM ICRI - Cranfield University, U.K. Jul. 2010 - Sep. 2012 Bachelor of Pharmacy (B. Pharma) Sardar Patel University, India. Jul. 2006 - Apr. 2010 Certificates & Training : Good Clinical Practice - ICH E6 (R2) Clinical Research Fastrack - TransCelerate Approve Dec. 2023 CfPIE Center for professional innovation & education Certificate for GCP Training Jul. 2019 DIA BABE Congress Certificate Jan. 2018Languages: English - Fluent Gujarati - Fluent Hindi - Fluent References: Available upon request.Page 3 of 3 |
