At a Glance
- Tasks: Support pharmacovigilance activities and manage safety reports to ensure patient safety.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance with a supportive culture.
- Benefits: Training opportunities, career development, and a friendly work environment.
- Other info: Diverse and inclusive workplace with global colleagues and a focus on well-being.
- Why this job: Make a real impact on patient lives while growing your career in healthcare.
- Qualifications: Life science graduate with 2-3 years of pharmacovigilance experience.
The predicted salary is between 65700 - 80300 $ per year.
We are Prime Vigilance (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.
Prime Vigilance 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, Prime Vigilanceprocedures 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
- Med DRA 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 within Prime Vigilanceand 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 Prime Vigilance?
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 Prime Vigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
We look forward to welcoming your application.
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PV Officer in Toronto employer: Ergomed Group
At PrimeVigilance, part of Ergomed PLC, we pride ourselves on being an exceptional employer that fosters a collaborative and globally connected work environment. Our commitment to employee growth is evident through our development opportunities and mentorship programs, ensuring that you can thrive in your pharmacovigilance career while making a meaningful impact in the field. Join us in a role where your contributions are valued, and be part of a team that prioritizes both professional and personal development.
