Himanshu Patel

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.
•  

PHARMACY ASSISTANT | Baxter                                                                          10/2022 – 03/2023 

• Prepared Centralized Intravenous Additive products, maintained the batch records and cross-functional communication with supervisors, pharmacists and quality team to ensure production workflow.

OPERATIONS SPECIALIST I | IQVIA                                                                   04/2021 - 09/2022 

• 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.

PHARMACOVIGILANCE ASSOCIATE | McKesson Canada                                08/2019 - 04/2021 

• 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.

PHARMACY ASSISTANT | IDA Drug Mart                                                            09/2017 - 07/2019 

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

SENIOR PHARMACOVIGILANCE SPECIALIST | Cognizant                            04/2016 - 08/2016 

• 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.

SENIOR PHARMACOVIGILANCE SPECIALIST | LabCorp (Sciformix)           10/2012 - 04/2016 

• 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.

Performed quality review of processed reports and supported the Quality Management.

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