Pharmacovigilance Manager

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

The Opportunity:

The Manager, Pharmacovigilance (PV) will act as support for PV Operations while overseeing assigned pharmacovigilance activities. This position is responsible for the timely collection, assessment and submission of adverse event (AE) reports related to applicable Client programs within the established time frames and align with the 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 be responsible for assisting the Operations team with maintaining and updating PV Standard Operating Procedures and Work Instructions. Assist in handling and managing case follow-up information, including the initial identification of missing data, requests for clarification of data and quality control (QC) processes. Responsible for creating and maintaining tracking spreadsheets and routinely providing metrics. Assist in supporting audits/inspections, including creation and maintenance of audit-ready training files.

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.
• 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 (i.e., project delivery, quality, regulatory performance).
• Responsible for operational oversight and decision making in matters relating to pharmacovigilance activities.
• Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with global regulatory requirements, Standard Operating Procedures (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 related activities as needed.
• Attends functional group meetings on a regular basis.
• Responds to client needs focusing on client satisfaction, and genuine commitment to teamwork.
• Supervise PV Associates.
• Oversee performance, provide coaching, and ensure high operational quality.
• Supervise PV Associates.
• Fulfill other duties as required for the position.

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

• Bachelor of Science or Master of Science in life sciences or health related field; Health Care Professional or equivalent experience preferred.
• Bilingual (French and English) is considered an asset.
• Minimum of 5 years in Pharmacovigilance or relevant industry experience.
• Minimum of 5 years in the pharmaceutical environment that is familiar with Health Canada rules and regulations relating to GxP processes.
• 2-3 years of experience managing PV Operations and a team.
• Experience with Good Pharmacovigilance Practice (GVP) and pharmacovigilance reporting.
• Experience in customer service.
• Proficiency using computerized information systems, internet, Microsoft Office applications, and electronic spreadsheets is required.
• Excellent communication skills and the ability to function well in a team-oriented environment.
• Expertise in writing and monitoring Deviations and CAPAs.
• Experience of working within cross-functional teams and multiple stakeholders.
• 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 ability to build effective working relationships with colleagues, management, and stakeholders.

Why join Sentrex?

We value our employees Our permanent full-time employees are provided with a:

• Competitive Salary and generous vacation entitlement
• Wellness Program (5 paid days off for your well-being)
• Paid Sick Days
• Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance
• Employee & Family Assistance Program

Sentrex Health Solutions is proud to be an equal opportunity employer demonstrated by our commitment to diversity, inclusion, belonging, equity, and accessibility. We provide a safe space for all team members to express their individuality within our corporate culture.

We encourage you to apply and accept all applications.  We realize that not every candidate will meet every single desired qualification.  If your experience looks a little different from what we have identified and you think you can bring value to the role, we would love to learn more about you

Accommodations can be made available upon request for those candidates taking part in the selection process.

Sentrex Health Solutions recognizes the importance of immunization to protecting our staff, customers, and members of the community from COVID-19. As such, and subject to any obligations under applicable human rights legislation, it will be a condition of employment that all new hires have received all required doses of a COVID-19 vaccine approved by Health Canada. Successful applicants will be required to provide proof of full vaccination prior to their start date.