Pharmacovigilance Associate

Sentrex Health Solutions•Markham, ON

9d•Hybrid

About The Position

Sentrex Health Solutions is a Canadian company that serves as a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and patients. They offer innovative solutions to ensure patient access and support for maximizing treatment outcomes, utilizing strategic distribution models, patient support programs, integrated technology, an in-house creative agency, and experienced teams. Their core capabilities include Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services, and HCP & Clinic Services. The Pharmacovigilance (PV) Associate role is based in Markham and involves managing the collection, processing, and reporting of Adverse Events (AEs) and Product Complaints in compliance with organizational and national pharmacovigilance requirements. Additionally, the PV Associate will assist with administrative aspects of the Quality Management System (QMS) to ensure compliance with GxP regulations.

Requirements

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

Nice To Haves

Bilingualism (English and French) is an an asset
Experience with QMS is an asset
Commitment to providing a high level of service to internal and external clients
Highly adaptable with a track record of success during times of growth and organizational change
Proven track record of developing trust and influence at multiple levels
Demonstrates an impactful and candid communication style
Exceptional organizational skills with the ability to build effective working relationships with colleagues, management, and stakeholders

Responsibilities

Managing the collection, processing, and reporting of adverse events (AEs)
Adhering and contributing to the structure and objective of compliance across the organization
Ensuring 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

Benefits

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
RRSP Matching Program
The anticipated base salary hiring range for this role is $62k to $73k annually. The final base salary will be determined based on relevant experience, skills, and internal equity.
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!