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

Ergomed Group; Lisboa; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

PrimeVigilance, part of Ergomed Group, is seeking a Qualified Person Responsible for Pharmacovigilance (QPPV) for EU and UK operations in a homebased role. You will lead PV system oversight, ensure regulatory compliance and act as primary contact for competent authorities.

The successful candidate will bring extensive PV experience, knowledge of global pharmacovigilance regulations, strong leadership, and fluency in English.

Qualifications

• Life-science education background (Medicine or Pharmacy) preferred.
• Solid knowledge of PV system operations and function.
• Strong knowledge of global regulations, standards and best practices for safety processing and reporting in post-marketing.
• Strong operational and managerial skills demonstrated by leading projects or functions.
• Strong experience in a PV role, proven track record as QPPV.
• Strong oral and written English communication skills.

Responsibilities

• Establish and maintain a PV information system accessible within the EU/UK community.
• Ensure prompt and complete responses to requests from Competent Authorities for safety data.
• Provide relevant safety information to authorities, including post-authorisation safety study plans.
• Maintain continuous availability to Competent Authorities and MAHs with robust back-up procedures.

Skills

PV system operations

Regulatory knowledge

Management experience

English proficiency

Education

Life-science degree (Medicine or Pharmacy)

Job description

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

• Full-time
• Department: QPPV Department

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

We look forward to welcoming your application.

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply