Senior PV Associate

Ergomed • Raleigh, NC

4d

About The Position

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

The Senior PV Associate supports project-team activities and performs work within the ICSR management unit to agreed scope and timelines. The role includes processing and following up Individual Case Safety Reports (ICSRs), supporting safety case management and related PV processes, and assisting the RA & PV Network Department as needed. Depending on the agreed assignment, responsibilities may include acting as the Local Contact Person for Pharmacovigilance (LCPPV) for a specified country and Person Responsible for Local Screening (PRLS) for a designated language.

PrimeVigilance describes a human-centric workplace that values employee experience, well-being, mental health, work-life balance, diversity, equity and inclusion. It offers training and career development opportunities, a supportive working environment, and collaboration with colleagues around the world, with English as the company language.

Requirements

• Life science graduate, or a qualification in pharmacy, nursing or another healthcare-related field, or experience in pharmacovigilance.
• At least 1 year of work experience in pharmacovigilance.
• Organizational skills, including attention to detail and multitasking.
• Management skills, including time and issue management.
• Advanced spoken and written English.
• 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 the agreed scope and timeframe.
• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements and timelines.
• Perform ICSR follow-up.
• Manage SAEs/SUSARs, including unblinding, clinical-trial reconciliation, protocol review and Safety Management Plan review.
• Perform clinical and partner reconciliations.
• Handle personal data protection activities.
• Handle Product Quality Complaints and interact with Quality Assurance.
• Interact with Medical Information.
• Perform MedDRA and WHO coding.
• Produce database outputs and reports, including data for monthly client reporting.
• Support workflow and resource management.
• Support PV 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 focused on diversity, equity and inclusion.

What This Job Offers

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