PV Officer

Ergomed Group; Toronto; Presencial; CAD 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Training and career development

Friendly working environment

Global collaboration

Resumo da oferta

PrimeVigilance, part of Ergomed PLC, is seeking a pharmacovigilance professional to support ICSR handling and regulatory-compliant case processing. You will engage in SAE/SUSAR activities, data protection, and liaise with Medical Information and QA teams while mentoring junior colleagues.

Ideal candidates have a Life Science background with 2–3 years PV experience and strong MS Office skills. The role offers development opportunities and a collaborative, globally connected work environment with

Qualificações

• Life science graduate, pharmacy, nursing or other healthcare qualification or experience in pharmacovigilance.
• 2–3 years of work experience in pharmacovigilance.
• Organization skills with attention to detail and multitasking.
• Strong planning and time management; solid MS Office proficiency.

Responsabilidades

• Provide support to project team activities for client and company.
• Process ICSRs from all sources in compliance with regulations and timelines.
• SAE/SUSAR management including unblinding and reconciliation.
• Maintain data protection and quality assurance interactions.
• Mentor and train junior staff within the department.

Conhecimentos

Pharmacovigilance compliance

Attention to detail

Multitasking

Planning & time management

MS Office proficiency

Technical aptitude

Formação académica

Life science or healthcare qualification

2–3 years pharmacovigilance experience

Ferramentas

MedDRA

WHO coding

Descrição da oferta de emprego

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.