Global and EU Qualified Person for Pharmacovigilance (f/m/x)

Farkas Kiss Endre legjobb állása Talentor Austria GmbH

bernadette.arnoldner@talentor.com;Markus.Gross@talentor.com;barbara.ulman@talentor.com;alexandra.thurnher@talentor.com;birgit.wandrak@talentor.com;office.austria@talentor.com;christine.leitner@talentor.com;thomas.zembacher@talentor.com;elke.gutzelnig@talentor.com;martina.tik@talentor.com;nina.schwartz@talentor.com;ayyuece.oeztuerk@talentor.com;nina.sattlegger@talentor.com;julia.gremel@talentor.com;cara.otahal@talentor.com;pernille.stein-engvoll@talentor.com;matthias.dietrich@talentor.com;vanesa.brahaj@talentor.com;katharina.gittsovich@talentor.com

Bewerbung fur Head of Technical (Facility) Management (w/m/x) - Technische Betriebsführung in der Forschung

Levél szövege

Lieber Talentor Austria GmbH!

Ich möchte mich bei Ihrem Unternehmen als Global and EU Qualified Person for Pharmacovigilance (f/m/x) bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

Our client with HQ in Vienna is an owner-managed pharmaceutical company, which strategically acquires prescription-only originator products worldwide. The owners and a team of international experts are striving to ensure the long-term availability of their products and to develop them further to benefit the current and future needs of their patients worldwide. Global and EU QPPV (f/m/x)with PV-expert team leadership skills YOUR FUTURE ROLEBeing the Global and EU Qualified Person for Pharmacovigilance (EU QPPV), you are responsible for the maintenance and further development of the company's pharmacovigilance (PV) system with given authority to influence the performance of the quality system and the PV activities in promoting, maintaining and improving compliance with the legal requirements. As QPPV you have access to the pharmacovigilance system master file (PSMF) and you ensure and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the PV system under the global and EU QPPV's responsibility. Your major accountabilities are: Maintain and further develop the PV-system and -structures, including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities on a global level Lead the PV-expert team members by example to ensure effective and cooperative cross-functional teamwork at the country, regional, and global levels Oversee the safety profiles of the company's marketed products and any emerging safety concerns Act as a single point of contact for the Competent Authorities on a 24-hour basis, and as the contact point for inspections Ensure and verify that the PSMF is constantly an accurate and up-to-date reflection of that safety system Contribute to the maintenance and further development of the PV-system, which ensures that information about all suspected adverse reactions, which are reported to the associates of the company, is collected and collated in order to be accessible at least at one point within the company Provide oversight over the functioning of the PV-system in all relevant aspects. Oversee development and implementation of standard procedural documents and processes Contribute to the preparation and approval of aggregate reports, Risk Management Plans (RMP), providing medical input to risk minimisation measures, RMPs and aggregate reports Provide 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). For requests from Competent Authorities, the EU QPPV will collaborate with colleagues on the response strategy, development and approval Review and approve, including sign-off of protocols of post-authorisation safety studies, e.g. conducted in the European Union (EU) or pursuant to a RMP agreed to in the EU Ensure full and prompt response to any request from Competent Authorities for the provision of information necessary for the benefit-risk evaluation of the products in collaboration with relevant departments Ensure that the conduct of PV and submission of all PV-related documents is in accordance with legal requirements and Good Pharmacovigilance Practice Promote, maintain, and improve compliance with PV legal requirements Maintain up-to-date knowledge of current PV regulations and collaborate with global PV on regulation changes Ensure PV-back-up procedures are appropriately established, maintained and tested (including PV Business Continuity, Disaster Recovery, and Deputy EU QPPV) Ensure compliance with all relevant regulatory and legal requirements and with MAH's Code of Business Conduct and Ethics Have the authority to make changes to the PV system Participate in all relevant meetings or committees or contractual arrangements of QPPV relevance Have 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 Keep up to date with data or reports generated from databases and other system JOB REQUIREMENTSM.D. or basic medical training or other education Several years of previous experience as (Deputy) EU QPPV Proven and solid knowledge of PV-system operations and functions Strong knowledge of position relevant global regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance in post-marketing activities Proven strong operational and managerial skills as demonstrated by leading previous projects or functions You are a person with high ethical standards and ready to commit to the company's values and behaviours Strong oral and written English communication skills - any additional language is beneficial Experienced in using Word, Excel, Power Point and Internet You are driven and satisfied by taking over responsibility OUR CLIENT OFFERSWork within a dynamic and successful healthcare company driven by highly qualified and experienced owners and associates worldwide A highly attractive compensation package including a performance-related bonus - taking into account YOUR QPPV-seniority PV-expert-team-leadership (approx. 6 team members) Opportunity to further develop the company's PV-structures Your individual and professional training and career development in a fast-growing and state-of-the-art healthcare company located in Vienna's city center ARE YOU INTERESTED?If you are interested in this unique and exciting challenge, we look forward to receiving your online application via our career portal. Our consultant responsible for you, Mag. Birgit Wandrak (birgit.wandrak@talentor.com), will contact you immediately after the receipt of your documents. We kindly ask you to support us in processing your documents in accordance with the GDPR and to refrain from sending an e-mail application. Jetzt bewerben