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Pharmacovigilance Associate, Markham
2 weeks ago
**Position Type**: Full Time
**Department**:QA & PV
**Work Location**: Markham, ON
**Work Arrangement**: Hybrid - (in office 2-3 days a week will be 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.**
**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
- Quarterly virtual social events
**The Opportunity**:
The Pharmacovigilance (PV) Associate is a role based in our facility in Markham and the key functions include managing the collection, processing, and reporting of Adverse Events (AEs) and Product Complaints in compliance with all organization and national pharmacovigilance requirements. The PV Associate will also be responsible for helping out with administrative aspects of the Quality Management System (QMS) to help drive compliance with GxP regulations through the QMS
**A Day in the Life (What you will do here)**:
- Managing the collection, processing, and reporting of adverse events (AEs);
- Adhering and contributing to the structure and objective of compliance across the organization.
- The organization, accuracy, and completeness of pharmacovigilance information for a variety of manufacturers and patient assistance programs, including audit preparation and management of Pharmacovigilance inbox
- Maintaining high compliance standards in regard to reporting timelines, quality of reporting, and assisting with responding to and tracking queries from stakeholders and manufacturers.
- Collecting, and recording data related to AE cases. Accountable for recognizing, triaging, and reporting as per the program or manufacturer requirements.
- Reporting and submitting reportable AEs to manufacturers as per Health Canada regulations and client guidelines.
- Electronic filing and archiving of PV documents to maintain audit readiness at all times
- Creating and reviewing Standard Operating Procedures (SOPs) and Work Instructions (WIs) as needed
- Conduct Pharmacovigilance trainings as needed
- Conducts period case reconciliation with applicable departments and clients as needed
- Collaborate with the internal SHS teams to help to find process efficiencies
- Help with administrating the Quality Management Systems
- Other tasks as required
**What you need to ensure you are set up for success**:
- Bilingualism (English and French) is an asset
- 3+ years of experience in Pharmacovigilance or relevant industry experience
- 3+ years of experience in the Pharma environment that is familiar with Health Canada rules and regulations relating to GxP processes.
- Good understanding of Health Canada GVP regulations
- Proficient in the Microsoft Suite of products with the ability to work in various databases
- Exceptional organizational skills and strong attention to detail.
- Demonstrated prioritization skills and ability to multi-task to meet tight deadlines.
- Proven analytical and problem-solving skills.
- Above average verbal and written communication skills.
- Ability to work as part of a team and have a collaborative mind-set to work with cross-functional partners;
- Experience with QMS is an asset.
**What makes you a great fit for this team**:
- Your commitment to providing a high level of service to your internal and external clients.
- You are highly adaptable with a track record of success during times of growth and organizational change.
- You have a proven track record of developing trust and influence at multiple levels.
- You demonstrate an impactful and candid communication style.
- You have exceptional organizational skills with the ab
