Full-Time Case Processing Manager (Pharmacovigilance)

Providing support to other activities undertaken by the project team on behalf of the client and the company.

Performing activities within the scope of ICSR management, adhering to timelines and agreed extent (including but not limited to):

• Processing Individual Case Safety Reports (ICSRs) from various sources, compliant with regulations, PrimeVigilance procedures, and client-specific requirements and timelines.
• 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
• Supporting PV processes related to ICSR management within PrimeVigilance and to clients
• Supporting ICSR SMEs and contributing as one of ICSR SMEs
• Supporting ICSR Operational Leads, as applicable
• 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 and Experience:

• Life science graduate, pharmacy, nursing, other healthcare-related qualification, or experience in pharmacovigilance
• Strong previous experience of PV in ideally a CRO environment

Skills and Attributes:

• 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)

What is the last date for applying to the job?

Which countries are accepted for this remote job?