Senior PV Officer

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 imeframe (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
Supporting ICSR SMEs or contributing as one of ICSR SMEs
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
Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
10-12 years of work 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
Advanced literacy (MS Office)

Employment type
Full-time

Work arrangement
Yes