Pharmacovigilance Submission Specialist

Há 1 mês


Lisboa, Portugal Primevigilance Tempo inteiro

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

We look forward to welcoming your application.

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