Pharmacovigilance Manager

Pharmacovigilance Manager

Company: Sentrex Health Solutions

Position Type: Full Time

Department: QA & PV

Work Location: Markham, ON

Work Arrangement: Hybrid – in office 2-3 days a week required

Work Hours: Standard Business Hours, Monday to Friday

Travel Required: No

A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in-house creative agency, and experienced, cross‑functional teams.

Our core capabilities include Specialty Pharmacy Services
, Customized Solutions for Warehouse, Wholesale & Distribution
, Patient Support Programs
, Strategic Creative Services as well as HCP & Clinic Services
.

• We are 100% Canadian with locations across the country
• State‑of‑the‑art facilities to provide high‑quality products and services
• The opportunity to be part of a winning, high‑performing team
• Collaborative, engaging workplace culture – we are passionate about our people!
• Flexible working environment that promotes a healthy work‑life balance
• Diverse and inclusive culture where your talent and commitment to excellence is welcomed and valued
• High‑growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry‑leading, in‑house corporate training offered throughout the year

The Manager, Pharmacovigilance (PV) will act as support for PV Operations while overseeing assigned pharmacovigilance activities. The position is responsible for the timely collection, assessment, and submission of adverse event (AE) reports related to applicable client programs within established time frames and in alignment with client standards. In this role, the individual will serve as primary oversight for receipt and accurate entry of AEs within the database and drive compliance with regulatory timelines.

The PV Manager will also assist the Operations team with maintaining and updating PV Standard Operating Procedures and Work Instructions, manage case follow‑up information, create and maintain tracking spreadsheets, support audits/inspections, and prepare audit‑ready training files.

• Managing the collection, processing, and reporting of adverse events (AEs)
• Adhering to and contributing to the structure and objective of compliance across the organization
• Organize, maintain accuracy, and completeness of pharmacovigilance information for a variety of manufacturers and patient assistance programs, including audit preparation
• Submit reportable AEs to manufacturers as per Health Canada regulations and client guidelines
• Create and review Standard Operating Procedures (SOPs) and Work Instructions (WIs) as needed
• Develop Pharmacovigilance training materials and conduct training as required
• Collaborate with internal organizational departments to help identify new opportunities and recommend initiatives
• Coordinate activities across functional project teams
• Review and report on overall client portfolio performance (project delivery, quality, regulatory performance)
• Responsible for operational oversight and decision‑making in matters relating to pharmacovigilance activities
• Monitor and manage workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with global regulatory requirements, SOPs, and safety processing guidelines
• Contribute to the performance management of SHS personnel PV‑related activities
• Prepare and participate in internal and external audits
• Complete Corrective and Preventative Action (CAPA) plans
• Liaise with the Quality Assurance Team to complete QC activities in support of PV activities as needed
• Attend functional group meetings on a regular basis
• Respond to client needs focusing on client satisfaction, and genuine commitment to teamwork
• Supervise PV…