Senior Submissions Officer

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: 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 device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

• 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

Qualifications

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

3-5 years of work experience in pharmacovigilance of which 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)

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer

• 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

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.