PV Officer

PrimeVigilance Ltd.; Toronto; On-site; CAD 60,000 - 90,000; Full time

Benefits offered by this job

Training opportunities

Career development

Global collaboration

Job summary

PrimeVigilance Ltd., part of Ergomed PLC, is a leading pharmacovigilance service provider seeking a Life Science graduate with 2-3 years in pharmacovigilance. The role involves ICSR processing, SAE/SUSAR management, data protection, and QA coordination across global clients.

You will support Medical Information interactions, handle regulatory outputs, and mentor junior staff within the ICSR team as needed. A detail‑oriented, globally minded professional will thrive in our diverse environment.

Qualifications

• Life science graduate or healthcare qualification with pharmacovigilance exposure.
• 2-3 years of work experience in pharmacovigilance.
• Strong organization and multitasking abilities.
• Excellent planning and time management.
• Solid technical skills and attention to detail.
• Proficient in MS Office applications.

Responsibilities

• Support project activities for clients and PrimeVigilance.
• Handle ICSR processing within regulatory timelines and procedures.
• Manage SAE/SUSAR activities and safety protocol reviews.
• Protect personal data and interact with Medical Information.
• Coordinate with QA on Product Quality and quality systems.
• Assist with MedDRA/WHO coding and generate client reports.

Skills

Life science

Pharmacovigilance

Organization

Time management

Technical skills

MS Office

Education

Healthcare qualification or degree

Tools

MS Office

Job description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations,PrimeVigilanceprocedures and in accordance with client specific requirements and timelines
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHOcoding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management
• Mentoring and training of new and more junior employees within the department
• Support of PV processes related to the ICSR management withinPrimeVigilanceand also toclients
• More senior colleague may perform tasks assigned as per SOP to more juniorposition
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• 2-3 years of work experience in pharmacovigilance
• Organization skills, including attention to details andmultitasking
• Planning and time management
• Technical skills
• Advanced literacy (MS Office)

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging

We look forward to welcoming your application.