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Pharmacovigilance Submission Specialist
4 meses atrás
**Company Description**
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.
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** Role and Responsibilities**
- Supporting the client in all aspects of safety reporting for aggregate reports and related activities
- Performing submissions of aggregate reports to all concerned parties
- Performing and oversight of reporting’s of Aggregate reports to Regulatory Authorities (RAs), Ethics Committees (ECs), Institutional Review Boards (IRB) and Investigators
- Tracking and archiving Aggregate reports submissions and exchanges in Aggregate reports tracker and archive, and Project specific tracker and archive
- Maintaining and oversight over aggregate and submission tracker
- eCTD compiling for aggregate reports
- eCTD sequence submission to clients/relevant regulatory bodies
- Maintaining Submissions mailbox
- Supporting the client with EudraVigilance registration and maintenance of EudraVigilance account for client
- Registration on behalf of client
- Support in all PV operations associated with safety reporting for aggregate reports and related activities
- Quality control of daily safety reporting activities
- Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
- Preparing invoice data and data reports on submission and project activities of department
- Supporting business development activities in department
- Participating in Audits and Inspections
**Qualifications**
- Life Science degree
- Previous experience in PV submissions
- Strong IT skills
- working with electronic databases and systems
- Excellent communication skills
- Fluency in English, additional languages are beneficial
- Organisational skills
**Additional Information**
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
