Qualified Person Responsible For Pharmacovigilance (Qppv) In The Eu And Uk (Homebased)

Ergomed; Madrid; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Training and career development

Friendly working environment

Global collaboration with colleagues

English as company language

Job summary

PrimeVigilance, part of Ergomed PLC, is seeking a QPPV to lead pharmacovigilance operations and ensure compliant safety information systems across Europe.

You will oversee safety data processing, regulatory reporting, and post-marketing surveillance while collaborating with global teams and maintaining strong relationships with authorities and MAHs.

Qualifications

• Life-science education background in Medicine (human or veterinary) or Pharmacy preferred.
• Solid knowledge of PV system operations and function.
• Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing.
• Strong operational and managerial skills as demonstrated by leading previous projects or functions.
• Strong experience in a PV role, with profound experience as QPPV.
• Strong oral and written English communication skills.

Responsibilities

• The EU QPPV is responsible for establishing and maintaining a system which ensures that information about all suspected adverse reactions reported to Company personnel is collected and collated to be accessible within the Community.
• Ensuring that requests from Competent Authorities for additional information needed for evaluation are answered fully and promptly.
• Providing to Competent Authorities any information relevant to evaluation of safety, including information on planned post-authorisation safety studies.
• Being continuously available to Competent Authorities and the MAH, ensuring adequate back-up procedures are in place.
• Overseeing the safety aspects of the company’s medicinal products, including safety profiles, emerging concerns, and commitments relating to safety or safe use.

Skills

PV knowledge

Leadership experience

English proficiency

Education

Life-science background

Job 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.

The EU QPPV is responsible for:

• The establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community;
• Ensuring that any request from the CAs for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly;
• Provision to the CAs, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on planned post-authorisation safety studies.
• Being continuously available to CAs in Member States and the Agency and the MAH, ensuring adequate back-up procedures are in place.
• Having an oversight of the safety aspects of the company’s medicinal products including an overview of medicinal product safety profiles, any emerging safety concerns, any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products and other relevant finding raised from studies/programmes conducted by the Company.

• Life-science education background Medicine (human or veterinary) or Pharmacy preferred
• Solid knowledge of PV system operations and function
• Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing
• Strong operational and managerial skills as demonstrated by leading previous projects or functions
• Strong experience in a PV role, profoundexperience as QPPV
• Strong oral and written English communication skills

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.