Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)

TN Spain; Madrid; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in pharmacovigilance seeks a Qualified Person Responsible for Pharmacovigilance (QPPV) to oversee safety aspects of medicinal products and ensure compliance with regulations. This role offers opportunities for personal and professional growth in a supportive environment.

Servicios

Internal training and career development opportunities

Focus on personal and professional growth

Friendly, supportive work environment

Opportunities to collaborate worldwide

Formación

• Extensive experience in PV roles, particularly as a QPPV.
• Strong knowledge of global regulations and standards.

Responsabilidades

• Establishing a system for adverse reactions reporting.
• Overseeing safety aspects of medicinal products.
• Responding to requests from Competent Authorities.

Conocimientos

Communication

Project Management

Pharmacovigilance

Educación

Life-science education

Medicine

Pharmacy

Descripción del empleo

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Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased), Madrid

Client:

Location: Madrid, Spain

Job Category: Other

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EU work permit required: Yes

Job Views:

2

Posted:

17.05.2025

Expiry Date:

01.07.2025

Job Description:

The EU QPPV is responsible for:

• The establishment and maintenance of a system which ensures that information about all suspected adverse reactions reported to the personnel of the Company and to medical representatives is collected and collated in a centralized location within the Community;
• Responding promptly and fully to requests from Competent Authorities (CAs) for additional information necessary for evaluating the benefits and risks of a medicinal product;
• Providing relevant information to CAs regarding the evaluation of the benefits and risks of a medicinal product, including information on post-authorisation safety studies;
• Maintaining continuous availability to CAs in Member States, the Agency, and the Marketing Authorization Holder (MAH), with appropriate back-up procedures;
• Overseeing the safety aspects of the company's medicinal products, including safety profiles, emerging safety concerns, conditions or obligations from marketing authorizations, and findings from studies conducted by the company.

Qualifications:

• Life sciences background; Medicine (human or veterinary) or Pharmacy preferred
• Solid knowledge of Pharmacovigilance (PV) system operations and functions
• Strong knowledge of global regulations, standards, and best practices in safety processing, reporting, surveillance, and compliance in the pharmaceutical industry post-marketing
• Operational and managerial skills demonstrated through leading projects or functions
• Extensive experience in PV, particularly as a QPPV
• Excellent oral and written English communication skills

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 backgrounds can contribute and grow.

We believe in a human-first approach to work because our people are our greatest strength, leading to our success in improving lives.

We offer:

• Internal training and career development opportunities
• Focus on personal and professional growth
• A friendly, supportive work environment
• Opportunities to collaborate with colleagues worldwide, with English as the company language

Our core values are central to our operations. If they resonate with you, PrimeVigilance could be a great place for you to join!

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

We look forward to receiving your application.