Senior Submissions Officer

Ergomed; North Carolina; On-site; USD 70,000 - 110,000; Full time

Job summary

PrimeVigilance, part of Ergomed Group, seeks an experienced Submission Specialist to support safety submissions and regulatory compliance in pharmacovigilance. You will collaborate with clients, manage submission processes, and help ensure quality in safety reporting.

Ideal candidates have 3–5 years in pharmacovigilance with at least 2 years on submissions, plus strong organization and communication skills. Global scope and ongoing growth opportunities are offered.

Qualifications

• Life science graduate, pharmacy, nursing or other healthcare related qualification.

Responsibilities

• Support the client in all aspects of safety submission.
• Assist the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards.
• Ensure knowledge of global regulatory reporting requirements to ensure compliance.
• Perform submissions of ICSPs/aggregate reports to all concerned parties.
• Exchange ICSPs with all concerned parties as per applicable documents.
• Provide support in all PV operations associated with Safety Reporting.
• Perform quality control of ICSR Reportability Assessment.
• Perform quality control of daily safety submission activities.
• Participate in trainings and maintenance of quality system documents for Safety Reporting.
• Provide training for junior team members.
• Act as SME for Submissions in audits and inspections representing Submissions processes and standards.

Skills

Organization

Multitasking

Time management

Communication

Pharmacovigilance

Submission experience

Education

Life science or healthcare degree

Job description

Medicine moves forward here. So willyou.

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-solversand experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America,Asiaand Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another andgood ideasare heard wherever they come from.

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

• 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 ICSPs/aggregate reports to all concerned parties
• Performing exchanges of ICSPs 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

• 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)

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’lljoin 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 theoutcome, becausesomeone is waitingonit.

• Agility and responsiveness:we movequickly, becausepatients 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.