Starszy Specjalista Ds. Bezpieczestwa Farmakoterapii

.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 itwhere your skills and values drive our collective progress and impact.Senior Specialist, GPRM(Starszy Specjalista ds. Bezpieczestwa Farmakoterapii)Location: Romania, Poland, Serbia, BulgariaKey accountabilities :Participate in the preparation of CCSI/CCDSParticipate in preparation/update of PV documents such as RMPs, REMS, PSURs, DSURs.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.Prepare responses to ad-hoc requests from regulatory agencies.Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines.Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.Liaison 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 to the candidates :Higher level of education/qualification in life science discipline or relevant experience, preferable medicine, pharmacy, veterinary degree.Have a relevant pharmacovigilance experience (2 years minimum) 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 is preferred).Knowledge of statistical software and use of drug safety database.Ability to work under pressure in order to meet tight deadlines.Ability to manage complex tasks in a matrix environment