Senior Pharmacovigilance Associate (Japanese fluency required)
Senior Pharmacovigilance Associate (Japanese fluency required)
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Job Description
If you join PrimeVigilance you can expect to work with teams of different sizes from small clinical trial to large generic post-marketing teams. We are always looking for proactive capable and motivated individuals who aim to surpass any target set in front of them
Responsibilities:
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
Database Outputs and Reports (including data for monthly reporting to clients)
Workflow & resource management
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
Qualifications :
Requirements:
Life science / bio medical background healthcare related degree (chemistry biology biotechnology veterinary science)
Experience working in Case Processing
Time and issue management delegation organization and multitasking skills with good attention to detail
Strong interpersonal and communication skills
English language skills and fluency in Japanese
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.
Our Offer
- Competitive salary
- Dynamic team of colleagues in a fast-growing company possibility for your quick career growth
- Multicultural environment English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance internal trainings provided by skilled professionals but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
