Junior PV Officer

PrimeVigilance • Raleigh, NC

6d

About The Position

PrimeVigilance is seeking a Junior PV Officer to provide support to project teams and perform activities within the ICSR management unit. This role involves processing Individual Case Safety Reports (ICSRs) from various sources in compliance with regulations and client-specific requirements. Responsibilities include ICSR follow-up, SAE/SUSAR management, reconciliation, product quality complaint handling, medical information interaction, MedDRA and WHO coding, and generating database outputs and reports. The role also encompasses workflow and resource management, mentoring junior employees, and supporting PV processes for both PrimeVigilance and its clients. More senior colleagues may delegate tasks to junior positions. The role may also involve supporting the RA & PV Network Department, acting as the LCPPV for a specified country, and serving as the PRLS for a designated language, as agreed with the line manager.

Requirements

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science)
• Demonstrated experience in Pharmacovigilance case processing
• Minimum 2 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

• 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
• 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
• 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

Benefits

• 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

What This Job Offers

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