Senior PV Associate

PrimeVigilance • Raleigh, NC

2d

About The Position

PrimeVigilance, part of Ergomed PLC, is a specialised mid-size pharmacovigilance service provider established in 2008, with staff across Europe, North America and Asia. The company provides Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance services to pharmaceutical and biotechnology partners across therapy areas, including medical devices.

The Senior PV Associate supports project-team activities and performs work within the ICSR management unit to agreed requirements and timelines. The role includes processing Individual Case Safety Reports from all sources in compliance with applicable regulations, company procedures and client-specific requirements. It also supports other pharmacovigilance processes for PrimeVigilance and its clients. As needed, the role supports the RA & PV Network Department, including acting as the Local Contact Person for Pharmacovigilance for a specified country and as Person Responsible for Local Screening for a designated language, as agreed with the line manager.

Requirements

• Life science graduate, pharmacy, nursing, another healthcare-related qualification, or experience in pharmacovigilance.
• Minimum 1 year of work experience in pharmacovigilance.
• Organizational skills, including attention to detail and multitasking.
• Management skills, including time and issue management.
• Advanced English proficiency, spoken and written.
• Advanced literacy in MS Office.

Responsibilities

• Support other activities undertaken by the project team on behalf of clients and the company.
• Perform activities within the ICSR management unit to agreed scope and timelines.
• Process Individual Case Safety Reports from all sources in accordance with applicable regulations, PrimeVigilance procedures, client-specific requirements and timelines.
• Perform ICSR follow-up and SAE/SUSAR management, including unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review.
• Perform clinical and partner reconciliation.
• Handle personal data protection activities.
• Handle Product Quality Complaints and interact with Quality Assurance.
• Interact with Medical Information.
• Perform MedDRA and WHO coding.
• Prepare database outputs and reports, including data for monthly client reporting.
• Support workflow and resource management.
• Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients.
• More senior colleagues may perform tasks assigned by SOP to more junior positions.
• Support the RA & PV Network Department as needed, including acting as the LCPPV for a specified country and PRLS for a 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.
• Equal-opportunities workplace and human-centric environment supporting diversity, equity and inclusion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed