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, and 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. 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.Position: Manager, GPRM Location: Romania, Poland, Serbia, Bulgaria, SloveniaKey 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: 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.#J-18808-Ljbffr
