Senior Submissions Officer

About the Company

PrimeVigilance is a global pharmacovigilance specialist dedicated to patient safety. We help clients navigate complex regulations while keeping patient safety central to every decision, from early development through post-marketing surveillance. Our work involves not only processing safety data but interpreting it to provide actionable insights. We foster a culture of kindness, flexibility, growth, and belonging across our teams in Europe, North America, South America, Asia, and Australia.

About the Role

Support the client in all aspects of safety submission, ensuring compliance with global regulatory reporting requirements. This role involves developing, documenting, implementing, and maintaining submission processes and standards, as well as performing and quality-controlling safety submissions and related activities.

Responsibilities

• Support the Submission Manager in developing, documenting, implementing, and maintaining submission processes and standards.
• Ensure personal knowledge and understanding of global regulatory reporting requirements to maintain compliance.
• Perform submissions of Individual Case Safety Reports (ICSRs) and aggregate reports to all concerned parties.
• Exchange ICSRs with all concerned parties as per applicable documents.
• Provide support in all pharmacovigilance operations associated with Safety Reporting.
• Perform quality control of ICSR Reportability Assessment and daily safety submission activities.
• Actively participate in trainings and maintain/develop quality system documents for the Safety Reporting area.
• Provide training for junior members of the team.
• Act as a Subject Matter Expert (SME) for Submissions in audits and inspections, representing Submissions business processes and standards.

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.
• Strong organizational skills, including attention to detail and multitasking.
• Effective management skills, including time and issue management.
• Excellent communication skills, with clear and effective interaction with internal and external stakeholders.
• Fluent in English (spoken and written).

Benefits

At PrimeVigilance (part of Ergomed Group), you’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. Our values—Quality, Integrity and Trust, Drive and Passion, Agility and Responsiveness, Belonging, and Collaborative Partnerships—guide how we work. You’ll contribute to bringing safe and effective pharmaceutical treatments to patients worldwide while being part of a diverse and inclusive environment.