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, PrimeVigilance procedures and in accordance with client specific requirements and timelines
Performing ICSR follow up
SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
Reconciliation (clinical, partners)
Personal data protection
Product Quality Complaint handling and interaction with Quality Assurance
Medical Information interaction
MedDRA and WHO coding
Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
More senior colleague may perform tasks assigned as per SOP to more junior position
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
Requirements:
Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
0-1 year of experience in pharmacovigilance, desirable but not required
Organization skills, including attention to detail and multitasking
Management skills, including time and issue management
Japanese - Professional level, English - Conversational level
Advanced literacy (MS Office)
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
- Collaborative Partnerships
We look forward to welcoming your application.