Himanshu Patel

Motivated and outcomes-driven professional with a degree in Masters in Clinical Research and a strong career portfolio showcasing first class theoretical and practical 7 years of experience in Pharmacovigilance and 2 years of experience in Pharmacy. Consultative, service-oriented team player with unwavering integrity and dedication to healthcare research and the continuous monitoring of medical drug effects to deliver patient-centric care.

PHARMACOVIGILANCE LEAD | Xediton Pharmaceuticals Inc. 03/2023 - Current

• Evaluating the pharmacovigilance reports and maintaining the pharmacovigilance system.
• Responsible to screen Canada Vigilance database and reporting to Health Canada and Partners as per the agreement and Health Canada Guidelines.
• Perform reconciliation with business partners as mentioned in the Pharmacovigilance agreements.
• Maintain PSUR/PBRER reports and create Annual Summary reports.
• Responsible for performing annual self-inspection and handled Health Canada audit for a period covering 6 years.
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• Prepared Centralized Intravenous Additive products, maintained the batch records and cross-functional communication with supervisors, pharmacists and quality team to ensure production workflow.

• Recorded ICSRs in Argus according to regulations, guidelines, SOPs and keep track in accordance with customer requirements to ensure stringent corporate and regulatory compliance.
• Performed all the Pharmacovigilance activities as per clients' requirements including triage, data entry, case finalization, and reviewed data and submission of the reports.
• Assisted the team with follow-up process, analyzing Corrective Action and Prevention Action (CAPA) for regulatory late cases and daily workflow distribution.

• Assisted in the development of new work and processes in response to identified root causes.
• Updated program documentation as required by the client, including program organizational charts.
• Produce client-facing reports on program’s compliance and effectiveness.
• Provided support during audits as required and performed reconciliations as per the requirements.

• Assisted the pharmacist to fill prescriptions, monthly inventory audit, data entry of the prescriptions.

• Contributed to database reconciliation in liaison with data management team.
• Monitored compliance standards and prepared Safety Management Plan.
• Responsible for accuracy and completeness of Pharmacovigilance information including audit preparation and electronic filing of PV documents.

• Processed post-marketing and clinical trial reports in Argus database and assessed the reports for seriousness, causality, expectedness, generated the queries and performed due diligence.
• Data entry of the safety data into database; reviewed the adverse events for completeness, accuracy and appropriateness using MedDRA for expedited reporting and manual narrative writing.
• Managed, mentored and led a case management team of thirty (30) members for compliance and quality assurance activities of the project.

Algonquin College - Canada 2017

Post-Diploma Program: Regulatory Affairs - Sciences

Gujarat University - India 2013

Master of Science: Clinical Research

Bombay College of Pharmacy - India 2013

Certification: Pharmacovigilance

Rajiv Gandhi University of Health Sciences - India 2010

Bachelor of Science: Pharmacy