Senior PV Officer

PrimeVigilance

6d

About The Position

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, Supporting ICSR SMEs or contributing as one of ICSR SMEs. More senior colleagues may perform tasks assigned as per SOP to more junior positions. 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.

Requirements

• 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)

Responsibilities

• 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
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed
• Acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country
• Taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

What This Job Offers

• Job Type: Full-time
• Career Level: Senior