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, and medical aesthetic devices. 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 Pharmacovigilance and Risk Management team we are looking for candidates for the following positions: Manager, GPRM Location: Romania, Poland, Serbia, Bulgaria, Slovenia Key accountabilities: Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals, validate, and prepare signal assessment reports or other related documents. Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals. Assist in aggregate safety data review. Participate in the preparation of CCSI/CCDS. Coordinate/co-author the finalization of documents such as RMPs/REMS, PSURs, and DSURs. Prepare responses to ad-hoc requests from regulatory agencies. Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines. Develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects. Liaise with internal stakeholders, including members of Medical Affairs, Data Management, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans. Requirements for candidates: Higher level of education/qualification in life science discipline or relevant experience, preferably medicine, pharmacy, or veterinary degree. Relevant pharmacovigilance experience (3-5 years) including signal detection. Thorough knowledge of signal detection and risk management. Good planning and organizational skills. Understanding of international pharmacovigilance regulations including GVP and requirements (post-marketing regulations preferred). Knowledge of statistical software and use of drug safety database. Ability to work under pressure to meet tight deadlines. Ability to manage complex tasks in a matrix environment. 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 a global position. Pleasant working atmosphere in an international environment. Opportunity for learning and growing in a positive and supportive team of professionals. All interested candidates are asked to send their 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 przesylanie CV z ponizsza klauzula: "Wyrazam zgode na przetwarzanie moich danych osobowych w celu rekrutacji zgodnie z art. 6 ust. 1 lit. a Rozporzadzenia Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w zwiazku z przetwarzaniem danych osobowych i w sprawie swobodnego przeplywu takich danych oraz uchwaly dyrektywy 95/46/WE (ogólne rozporzadzenie o ochronie danych) jak równiez zgodnie z Ustawa Dz.U.2018.1000 O ochronie danych osobowych".
Bausch Health is an EEO/AA employer M/F/D/V.
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