PV Associate

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 

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 

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