Senior Submissions Officer

Ergomed • Raleigh, NC

8d

About The Position

PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. This role supports the client in all aspects of safety submission, ensuring compliance with global regulatory reporting requirements. The position involves performing submissions and exchanges of ICSRs, providing support in PV operations, and conducting quality control of safety reporting activities. The company fosters a culture of kindness, flexibility, growth, and belonging, with a focus on interpreting safety data to provide actionable insights. This role offers a purpose-driven career with global reach and opportunities for professional growth.

Requirements

• Life science graduate, pharmacy, nursing or other healthcare related qualification
• 3-5 years of work experience in pharmacovigilance with at least 2 years of experience working on submissions
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• Communication skills, including clear and effective interaction with internal and external stakeholders
• English - fluent (spoken, written)

Responsibilities

• Supporting the client in all aspects of safety submission
• Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards
• Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance
• Performing submissions of ICSRs/aggregate reports to all concerned parties
• Performing exchanges of ICSRs with all concerned parties as per applicable documents
• Providing support in all PV operations associated with Safety Reporting
• Performing Quality control of ICSR Reportability Assessment
• Performing Quality control of daily safety submission activities
• Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
• Provide training for junior members of the team
• Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards

What This Job Offers

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