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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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.
