Pv Specialist

**Position Type**: Full Time

**Department**: Pharmacovigilance

**Work Location**: Markham, ON, Canada

**Work Arrangement**: Hybrid

**Work Hours**: Monday to Friday - standard business hours

**Travel Required**: Occasionally as required

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.**

**Come and join our team But first, let us tell you why we love working here**:

- 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 a 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 Opportunity**:
The PV Specialist-Governance and Compliance is a full-time permanent hybrid role based at Sentrex Markham. The PV G&C Specialist is responsible for supporting the development, implementation, and oversight of PV governance frameworks and compliance systems. This role ensures that all pharmacovigilance activities are conducted in accordance with applicable global regulations, Good Pharmacovigilance Practices (GVP), and internal policies. The PV G &C specialist will play a key role in maintaining inspection readiness, managing compliance metrics, and driving continuous improvement across PV processes.

**A Day in the Life (What you will do here)**:
**Governance & Compliance Oversight**
- Support the development, revision, and lifecycle management of PV Governance & Compliance-related SOPs, Work Instructions (WIs), and other governance documents.
- Supporting the management and resolution of deviations, ensuring coordination, documentation and follow-up with internal teams (PSP, Partner Pharmacy, Subcontractors) and submission of deviation reports to the clients.

**PV Training & Documentation**
- Manage PV training compliance, including onboarding, annual retraining for PSPs.
- Coordinating and maintaining training records and administrative documentation in alignment with PV standards.
- Oversee document translations and ensure bilingual compliance where applicable (e.g., French/English requirements)
- Ensure timely completion of trainings of assigned personnel for internal Pharmacovigilance procedures.
- Management of PV training across different client learning management systems before program launch.

**PV Metrics, Insights & Reporting**
- Compile and analyze data to develop PV compliance metrics for internal and client reporting
- Prepare dashboards to support governance reviews and audits
- Review of real-world PV data for safety data trends (potentials signals, adherence).

**PV Audit & Inspection Readiness**
- Support internal and external PV audits and regulatory inspections (e.g., MAH, Health Canada, US FDA, MHRA, BfArM etc.)

**Process Improvement**
- Conduct gap analyses and recommend enhancements to PV processes to ensure operational excellence and regulatory alignment
- Collaborate with cross-functional teams (QA, PSP, Pharmacy) to implement best practices and harmonize procedures
- Supporting the implementation of Pharmacovigilance (PV) systems.
- Other duties as assigned by your manager

**What you need to ensure you are set up for success**:

- Bachelor of Science Degree in related field (e.g. biomedical science, pharmacy). Master of Science an asset.
- Good knowledge of Global Pharmacovigilance regulations
- 5 to 7 years related experience in pharmacovigilance and reporting to government authorities.
- Previous experience interacting with Health Canada or other regulatory agencies in Pharmacovigilance.
- Excellent written and verbal communication skills.
- Strong interpersonal skills with the ability to build strong working relationships with key stakeholders.
- Ability to handle competing priorities.
- Prior experience in a drug/medical information position within the Canadian pharmaceutical industry
- Experience working in PV Databases required.
- Bilingual (English