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

Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)
Bucureşti
Bucharest, Bucharest, Romania

Job Description

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
  - authorisation safety studies.
• Being continuously available to CAs in Member States and the Agency and the MAH, ensuring adequate
  - 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
  - marketing
• Strong operational and managerial skills as demonstrated by leading previous projects or functions
• Strong experience in a PV role, profound experience as QPPV
• Strong oral and written English communication skills

Why Prime
Vigilance?   

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a
- 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 Prime
Vigilance could be a great company to join!   

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

We look forward to welcoming your application.