Senior Submissions Officer

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

Company Description

Medicine moves forward here. So will you.

Company Description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

Job Description

• 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 ICSR`s/aggregate reports to all concerned parties
• Performing exchanges of ICSR` 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

Qualifications

• 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)

Additional Information

Why PrimeVigilance?

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.