PV Associate Japan
Job Summary
- Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
- Contributes to achieving companys goals and objectives
- Works under supervision of more experienced colleague
- 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)
- Product Quality Complaint handling and interaction with Quality Assurance
- Medical Information interaction
- Database Outputs and Reports (including data for monthly reporting to clients)
Qualifications :
We expect:
- Degree educated in a Life Sciences subject
- Ambition to work within Pharmacovigilance
- Fleuncy in English and Japanese
- Good IT skills (MS Office)
- Excellent organization skills with attention to detail
- Excellent interpersonal and communication skills
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
- Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.
Remote Work :
No
Employment Type :
Full-time
About Company
Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more