Senior Submissions Officer

Ergomed • Raleigh, NC

15h

About The Position

PrimeVigilance, a specialized pharmacovigilance service provider established in 2008 and part of Ergomed PLC, is seeking a Senior Submissions Officer. The company has experienced consistent global growth and offers services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing itself as a global leader in its field. The company emphasizes investment in staff through training and development, valuing employee experience, well-being, and mental health, recognizing the importance of work-life balance for employee satisfaction and high-quality client service. This role offers an opportunity to join an exciting journey focused on making a positive impact on patients' lives.

Requirements

• Life science graduate, pharmacy, nursing or other healthcare related qualification
• 3-5 years of work experience in pharmacovigilance
• At least 2 years must have been in a dedicated submissions role
• 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)

Responsibilities

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

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

What This Job Offers

• Job Type: Full-time
• Career Level: Senior