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Qppv (M/F)

Michael Page Portugal

19.07.2021 | Lisboa | Referência: 2026056


Qppv  (m/f)

Referencia: JN -072021-2940794
Adicionado em 19.07.2021
Sobre os nossos clientes
Pharmaceutical area.

Descriçăo da oferta

Company in the pharmaceutical area intends to increase its structure with a QPPV.

Principais responsabilidades

* Establishment and maintenance of the Pharmacovigilance System;

* Having sufficient authority to influence the performance of the quality system (e.g. SOPs, 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) and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements;

* Performance of Pharmacovigilance audits and vigilance of health products;

* Having access to the PSMF and be in a position of authority to ensure and to verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system;

* 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 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);

* 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.

Perfil desejado

* Degree (Pharmaceutical sciences-preferential);

* Deep knowledge of pharmaceutical legislation with emphasis in GVPs;

* EudraVigilance User Training Course;

* eXtended EudraVigilance Medicinal Product Dictionary Training Course;

* Computer skills as a user (advanced Excel knowledge);

* Portuguese language (very good, oral and written);

* English language (very good, oral and written);

* Organisational skills and project management;

* Ability to work in a team;

* Ability to perform the work and respond in short periods of time;

* Autonomy.

Benefícios adicionais

An excellent opportunity for professional and personal development.

Contacto da Michael Page
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