PV Officer

PrimeVigilance

1d • Remote

About The Position

PrimeVigilance (part of Ergomed PLC) is a specialized pharmacovigilance service provider established in 2008. We have achieved global organic growth year after year, with staff across Europe, North America, and Asia covering Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We provide first-class support to pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing ourselves as a global leader in the field. We cover all therapy areas, including medical devices. We invest in our staff through an excellent training and development platform, valuing employee experience, well-being, and mental health. We acknowledge that a healthy work-life balance is critical for employee satisfaction and fosters an environment for high-quality client service. Join us in making a positive impact on patients' lives.

Requirements

• Life science graduate, pharmacy, nursing, other healthcare-related qualification or experience in pharmacovigilance.
• 2-3 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 the ICSR management unit within the agreed extent and timeframe, including processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, and 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 ICSR management within PrimeVigilance and also to clients.
• More senior colleagues may perform tasks assigned as per SOP to more junior positions.
• Supporting ICSR SMEs.
• 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: Mid Level