Senior PV Submissions Associate

Ergomed • Raleigh, NC

11h

About The Position

PrimeVigilance, part of Ergomed PLC, is a specialized pharmacovigilance service provider established in 2008. We have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance provides first-class support to our small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and has become one of the global leaders in its field. We cover all therapy areas, including medical devices. We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction, nurturing an environment from which a high-quality client service can be achieved. Join us in this exciting journey to make a positive impact on patients' lives.

Requirements

• Life science graduate, pharmacy, nursing or other healthcare related qualification
• 1-2 years of work experience in pharmacovigilance
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• English - fluent (spoken, written)

Responsibilities

• Supporting the client in all aspects of safety submission
• 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 Submission
• 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 Submission area

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