Himanshu Patel
Services provided: Health Science Professionals
About 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.
Experience
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.
Education
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
Professionals offering similar services to those of Himanshu Patel
Professionals in the same Pharmaceutical / Bio-tech sector as Himanshu Patel
Professionales offering Health Science Professionals services
Professionals from different sectors near Brampton, Ontario
Other users who are called Himanshu
Jobs near Brampton, Ontario
-
Manager, Finance Systems
Found in: Talent CA C2 - 3 days ago
Royal Bank of Canada> Toronto, CanadaJob Summary · Job Description · What is the opportunity? · As a Manager, Finance Systems you will maintain EPM environment and ensure integrity of Financials related to Plan, Forecast, Stress Test and Actual. You will support forecasting and planning activities and provide guidan ...
-
cook
Found in: Talent CA 2 C2 - 3 days ago
2864792 Ontario Inc Markham, CanadaEducation: College/CEGEP · Experience: 1 year to less than 2 years · Work setting · Restaurant · Tasks · Prepare and cook complete meals or individual dishes and foods · Prepare dishes for customers with food allergies or intolerances · Prepare and cook special meals for patients ...
-
Net Developer- Manufacturing
Found in: Jooble CA O C2 - 4 days ago
TechBlocks India Vaughan, ON, CanadaTechBlocks is a leading global digital product development firm. Weunify strategy, design and technology with continuous growth-centricdigital product engineering solutions for F500 companies and globalbrands including Bell Telecom, Bausch Health (Previously ValeantPharma), Honda ...