PpBe the expert behind safer medicines-leading signal detection and global safety strategy. /ppProclinical is seeking a Senior Pharmacovigilance Specialist to support safety management activities for pharmaceutical products in the cardiovascular space. In this role, you will lead critical pharmacovigilance processes, including safety signal management, aggregate report preparation, and regulatory responses. You will also act as a subject matter expert on global safety regulations and guidelines, ensuring compliance and maintaining product integrity throughout clinical trials and post-marketing phases. /ppPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /ph3Responsibilities /h3ulliLead safety signal management processes, including detection, tracking, documentation, and evaluation of safety data. /liliSynthesize data from multiple sources and author signal evaluation reports. /liliManage literature reviews to identify relevant safety information. /liliOversee the preparation, review, and finalization of aggregate safety reports, such as PSURs, DSURs, Risk Management Plans (RMPs), and other related documents. /liliRespond to safety-related inquiries from regulatory authorities. /liliCollaborate with cross-functional teams, including Safety, Clinical Development, Medical Affairs, and Regulatory, to support investigational programs and clinical trial activities. /liliProvide clinical judgment and analysis for case information and safety data. /liliFacilitate Safety Signaling Team meetings and ensure alignment on safety strategies. /li /ulh3Key Skills and Requirements /h3ulliStrong ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats. /liliExpertise in pharmacovigilance processes, including safety signal management, aggregate report authoring, and regulatory compliance. /liliSolid understanding of global clinical trial and post-marketing safety regulations. /liliProficiency in data processing tools such as Excel, PowerPoint, and Word, as well as familiarity with safety database systems. /liliDemonstrated leadership and collaboration skills within cross-functional teams. /liliStrong organizational abilities, with the capacity to prioritize tasks independently. /liliEducational background in biological or natural sciences, health disciplines, or an advanced degree (e.g., PhD, MPH, NP, PharmD). /liliExperience in pharmacovigilance, particularly in aggregate safety reporting and signal management. /li /ulpIf you are having difficulty in applying or if you have any questions, please contact bOlivier Worch /b at /ppIf you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page. /p /p #J-18808-Ljbffr