Global Submissions Lead - Pharmacovigilance & Safety

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

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.