Senior Submissions Specialist – PV Compliance

PrimeVigilance; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

PrimeVigilance, a global pharmacovigilance specialist, is seeking a Safety Submissions professional in Raleigh, NC. You will support clients in all safety submissions and help maintain submission standards while ensuring compliance with global regulations.

This role emphasizes accuracy, timely delivery and collaboration with cross-functional teams. Ideal candidates have a life sciences background, 3–5 years in PV and at least 2 years on submissions, with excellent organization and communication

Qualifications

• Life science graduate, pharmacy, nursing or healthcare qualification.
• 3–5 years in pharmacovigilance with at least 2 years on submissions.
• Excellent organization, multitasking and attention to detail.
• Strong communication with internal and external stakeholders.

Responsibilities

• Support client in all safety submission aspects
• Assist Submission Manager with development, documentation and maintenance of submission processes
• Ensure knowledge of global regulatory reporting requirements for compliance
• Perform submissions of ICSR and aggregate reports
• Exchange ICSR with all involved parties per documents
• Provide PV operations support for Safety Reporting
• Quality control of ICSR Reportability Assessment
• Quality control of daily safety submission activities
• Participate in trainings and maintain QA documents for Safety Reporting
• Provide training for junior team members
• Act as SME for Submissions in audits and inspections

Skills

Pharmacovigilance experience

Communication skills

Organization and multitasking

Time management

Attention to detail

Education

Life science degree / healthcare qualification

Pharmacy / Nursing background

Job description

PrimeVigilance, a global pharmacovigilance specialist, is seeking a Safety Submissions professional in Raleigh, NC. You will support clients in all safety submissions and help maintain submission standards while ensuring compliance with global regulations.

This role emphasizes accuracy, timely delivery and collaboration with cross-functional teams. Ideal candidates have a life sciences background, 3–5 years in PV and at least 2 years on submissions, with excellent organization and communication