Specjalista, Biuro QPPV oraz PSMF

Job title:

Specjalista, Biuro QPPV oraz PSMF

Company:

Bausch Health

Job description

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.We are all in it together to make a difference. Be a part of a culture that doesn’t just wait for change but actively creates it-where your skills and values drive our collective progress and impact.In our Global PV & Risk Management Team we are looking forSpecialist, Office of QPPV and PSMF(Specjalista, Biuro QPPV oraz PSMF)Location: Warsaw, PolandKey accountabilities:Support activities of the EEA QPPV Office with the following activities:

• maintenance and update of the global Pharmacovigilance System Master File (PSMF) to ensure the content is in line with relevant regulations, created, approved and distributed in a timely manner as appropriate;
• support LPPVs regarding local PSMFs;
• liaising with other global functions to collate required information within timelines;
• support management of the monthly reporting to the EEA QPPV Office;
• support LPPV network (e.g., LPPV SharePoint activities, trainings);
• assistance with vendor oversight;
• other EEA QPPV activities as applicable.

Support activities of the Global Risk Management Team with the following activities:

• signal detection and analysis activities;
• aggregate safety data review;
• safety website monitoring
• other Global Risk Management Team activities as applicable.

Requirements to the candidates:

• University degree with Pharmaceutical/Medical/Scientific background.
• A minimum of 1 year professional experience in pharmacovigilance.
• Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities.
• Understanding of International Pharmacovigilance regulations including GVP and requirements.
• Ability to work under pressure in order to meet tight deadlines.
• Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.
• Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat).
• Excellent communication skills and ability to work within the team and cross-functionally.
• Fluency in English.

We Offer:

• Working in global position.
• Pleasant working atmosphere in international environment.
• Opportunity for learning and growing in positive and supportive team of professionals.

All interested candidates are asked to send the CV in English including GPDR clause:„I hereby give consent for my personal data included in my application to be processed for the purposes of the recruitment process under the European Parliament’s and Council of the European Union Regulation on the Protection of Natural Persons as of 27 April 2016, with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive)”.Osoby zainteresowane prosimy o przesyłanie CV z poniższą klauzulą:
„Wyrażam zgodę na przetwarzanie moich danych osobowych w celu rekrutacji zgodnie z art. 6 ust. 1 lit. a Rozporządzenia Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE (ogólne rozporządzenie o ochronie danych) jak również zgodnie z Ustawą Dz.U.2018.1000 O ochronie danych osobowych”.

Expected salary

Location

Warszawa, mazowieckie

Job date

Sun, 04 Aug 2024 01:34:13 GMT

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