PV Associate - Dutch speaker

Ergomed; Madrid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A global pharmacovigilance service provider in Madrid is seeking candidates for a role in ICSR management. The position emphasizes collaboration and processing Individual Case Safety Reports. Ideal candidates should have a life science background and fluency in English and Dutch. The company promotes a supportive environment and provides opportunities for career development and personal growth. Join us to contribute to patient safety and thrive in a diverse workplace.

Servicios

Training and career development opportunities

Friendly, supportive working environment

Opportunity to work with international colleagues

Formación

• Healthcare related degree (chemistry, biology, biotechnology, veterinary science) is expected.
• Previous experience is not required.
• Interested in pursuing a career in pharmacovigilance.

Responsabilidades

• Manage effective cooperation with clients in the area of ICSR Management.
• Process Individual Case Safety Reports (ICSRs) in compliance with regulations.
• Perform ICSR follow-up and SAE/SUSAR Management.

Conocimientos

Fluency in English

Fluency in Dutch

Good IT skills (MS Office)

Excellent organization skills

Interpersonal and communication skills

Educación

Life science / biomedical background

Descripción del empleo

We are PrimeVigilance (part of Ergomed Group), 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

• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company´s goals and objectives
• Works under supervision of more experienced colleague
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• Database Outputs and Reports (including data for monthly reporting to clients)

Qualifications

We expect:

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required.
• Interested in pursuing a career in pharmacovigilance
• Fluency in English & Dutch
• Good IT skills (MS Office)
• People who are excited to learn and contribute to patient safety
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication 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

Core values

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

We look forward to welcoming your application.