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PV Assistant

PrimeVigilance -
Raleigh, NC

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Job Details

Full-time
3 days ago

Qualifications

Incident reporting compliance
Healthcare incident report preparation
Adverse event reporting
Regulatory compliance
Filing
English
Microsoft Office
Administrative experience
High school diploma or GED
Data management
Communication skills
Entry level
Under 1 year

Full Job Description

Company 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

Receiving and returning safety messages and acknowledge receipt, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
Perform other miscellaneous administrative tasks, as applicable
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) that require simple processing (e.g. solicited cases with limited information, minimal information reports, E2B cases without narrative writing, data clean-up activities and standardised form reports) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
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

High school or university graduate

Experience desirable, but not required in administrative position

Good communication skills
Experience with administrative work

English - advanced (spoken, written)

Advanced literacy (MS Office)

Additional Information

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
Collaborative Partnerships

We look forward to welcoming your application.

Quick Apply

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