Regulatory Compliance Risk Management

G U R P R E E T K A U R

CA L E D O N, ONT A R I O L 7 C 3 X 8

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Accomplished Pharmacovigilance professional with over three years of experience in ensuring drug safety and regulatory compliance within the pharmaceutical industry. Expertise in monitoring and reporting adverse drug reactions, ensuring regulatory compliance, and conducting safety data analysis. Proven ability to support clinical trials, manage safety databases, and contribute to the development of risk management strategies. Dedicated to maintaining the highest standards of patient safety and regulatory adherence. Core Competencies:

Adverse Event Monitoring Regulatory Compliance

Risk Management Safety Data Analysis

Clinical Trial Safety Signal Detection

Team Leadership Process Optimization

Strong communication Cross-functional Collaboration Technology Specialties:

Safety Databases: Argus, ArisG, Veeva Vault

Clinical Trials Databases: Medidata Rave, Vault CDMS, ICON, IBM

Literature Monitoring: xEVMPD, MLM, Local Literature and Global Literature

Client Relationship Management Software (CRM)

Quality Management System (QMS)

MS Office: Word, Excel, Outlook, PowerPoint

Operating Systems: Windows XP, Vista, 7, 10, and 11 E X P E R I E N C E

PAREXEL INTERNATIONAL SERVICES LIMITED, Ontario, Canada 2021 – 2024 Drug Safety Associate

Performed pharmacovigilance (PV) and medical device vigilance (MDV) activities for clients in accordance with company SOPs, working practices, and regulatory guidelines. Managed Individual Case Safety Reports (ICSRs) for various case types, including clinical trials, post-market surveillance, spontaneous reports, and literature cases. Responsibilities encompassed triage, initiation, data entry, case processing, distribution, and submission workflows. Demonstrated expertise as a business and system administrator for pharmacovigilance databases.

Expertise in end-to-end case processing using Argus and Veeva Vault databases for processing ICSRs, adhering to SOPs (standard operating procedure) and WIs (work instructions), encompassing triage, duplicate search, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness and expectedness assessments of adverse events against various labeling documents (such as SmPC, CDS, IB), causality assessment, reportability assessment, expedite, and periodic reporting.

Recognized adverse event (AE), adverse drug reactions (ADR), adverse drug experience (ADE), and medical device incident (MDI) information from the source document.

Processed product quality complaints (PQC) in adherence to SOP and WIs.

Screened medical and scientific literature for safety information.

Ensured accuracy and completeness of pharmacovigilance information for multiple manufacturers and patient assistance programs, including audit preparation and management of pharmacovigilance inbox.

Generated regulatory report forms (MedWatch, CIOMS, and E2B) for reportable events, facilitating client GURPREET KAUR PAGE 2

submissions to regulatory authorities, license partners, and investigators and institutional review boards(IRBs).

Performed QC (quality check) on adverse event reports as directed by WIs.

Prepared and conducted solicited follow-up letters and data clarifications by consistently using Argus and Veeva vault features such as action items, contact logs, and worklists for communication and follow-up requests.

Generated line listing reports while ensuring strict adherence to regulatory compliance timelines.

Electronically filed and archived PV documents to ensure audit readiness.

Conducted pharmacovigilance trainings as required.

Handled RCAs (root cause analyses) and CAPAs (corrective and preventive actions) to ensure quality management and standards.

Experienced in periodic safety reports (e.g., DSUR, PSUR, PBRER, SAE, RMPs) and signal detection.

Contributed to the preparation and review of additional regulatory reporting documents (e.g., IND, DSUR, and Annual Reports).

Maintained up-to-date knowledge of ICH (International Conference on Harmonization), GDP (Good documentation practices), GCP (Good clinical practice), EU pharmacovigilance legislation (EMEA), US FDA, Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines, and familiarity with the Canada Vigilance-MedEffect Program as relevant to the assigned role, ensuring compliance and performing assigned duties accordingly with regular updates as needed.

Maintained confidentiality of patient, client, and corporate information consistently.

Reviewed hardcopy and/or electronic SAE, device incident, pregnancy report forms, and supplementary reports to verify the redaction of personal identifying information, as required.

Generated queries for critical or missing information, forwarded them to the Data Manager for posting to the clinical database, and generated data clarification forms (DCFs) to send queries directly to study sites.

Administered and supported Quality Management Systems (QMS) to ensure adherence to quality standards and regulatory requirements.

Demonstrated expertise in clinical case reconciliations and follow-ups utilizing clinical EDC databases such as Rave, Medidata, Vault CDMS, ICON, and IBM.

Conducted periodic case reconciliation with departments and clients.

Comprehensive understanding of the drug development process, encompassing drug safety principles and various phases of clinical trials.

E D U C A T I O N

Master of Science, Microbial Biotechnology, PUNJAB UNIVERSITY, Chandigarh, India (2020) Bachelor of Science, Biotechnology, CHANDIGARH UNIVERSITY, Ajitgarh, Punjab, India (2017) P R O J E C T S A N D T R A I N I N G S

Completed Qualified Pharmacovigilance Professional with ICSR processing from ACADEMYOFCLINICAL INTELLIGENCE

(a pharmacovigilance training management company), Chandigarh.

Competed dissertation in the field of Microbial Biotechnology titled “Evaluation of Salicylic acid derivatives for Antimicrobial activity against Staphylococcus epidermidis” under the guidance of Dr. Rachna Singh, PUNJAB UNIVERSITY.

Completed four weeks of industrial training in clinical research and experimental biotechnology at PHARMA INSTINCT, Chandigarh.

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