The EU QPPV is responsible for the establishment and maintenance of the marketing authorization holder’s pharmacovigilance system in close cooperation with the Deputy EU QPPV and marketing authorization holder.

What will be your key responsibilities:

  • act as EU QPPV on assigned projects, as applicable.
  • oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance) ;
  • close cooperation with the Marketing Authorization Holder as well as related departments and functions;
  • close cooperation with the Deputy QPPV.
  • acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections;
  • having an overview of medicinal product safety profiles and any emerging safety concerns;
  • having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products;
  • having awareness of risk minimisation measures;
  • being aware of and having sufficient authority over the content of risk management plans;
  • being involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU;
  • having awareness of post-authorisation safety studies requested by a competent authority including the results of such studies;
  • ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;
  • ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency;
  • ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product;
  • providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency;
  • providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).

What experience should you have:

  • medical degree (e.g. Pharmacy, Doctor of medicine) – higher medical education (e.g. field specialization, PhD) is preferable
  • previous experience as EU QPPV or Deputy QPPV
  • detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
  • experience working with a safety database
  • knowledge of web-based communication tools for conferencing (Skype/Teams, WebEx, etc.)
  • fluent verbal and written English
  • ability to delegate and oversee work of junior staff
  • ability to provide training to junior staff
  • excellent team player, able to build an effective team
  • organizational and time-management skills, able to prioritize work and adhere to deadlines
  • excellent communication skills
  • maintains a positive, result oriented work environment

What do you get in return:

Hybrid or remote working (Use of our offices in various locations, co-sharing work space or remote options available)
5 weeks holiday plus national holidays in your given location
3 personal days
Flexible benefits, based on location
Home office stipend
Annual bonus program
Other employee Bonuses (spot bonuses and employee nominated bonuses)
Dog friendly offices
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