Case Processing Manager
Case Processing Manager
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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 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
Mentoring and training of new and more junior employees within the department
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
Supporting ICSR SMEs and contributing as one of ICSR SMEs
Supporting ICSR Operational Leads as applicable
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
Excellent communication (written and verbal) skills
Organization skills including attention to details and multitasking
Delegation skills
Planning and time management
Technical skills
Team working
English fluent (spoken written)
Additional Information :
Why PrimeVigilance
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
