PpBe the expert behind safer medicines-leading signal detection and global safety strategy. /p pProclinical 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. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities /h3 ul liLead safety signal management processes, including detection, tracking, documentation, and evaluation of safety data. /li liSynthesize data from multiple sources and author signal evaluation reports. /li liManage literature reviews to identify relevant safety information. /li liOversee the preparation, review, and finalization of aggregate safety reports, such as PSURs, DSURs, Risk Management Plans (RMPs), and other related documents. /li liRespond to safety‑related inquiries from regulatory authorities. /li liCollaborate with cross‑functional teams, including Safety, Clinical Development, Medical Affairs, and Regulatory, to support investigational programs and clinical trial activities. /li liProvide clinical judgment and analysis for case information and safety data. /li liFacilitate Safety Signaling Team meetings and ensure alignment on safety strategies. /li /ul h3Key Skills and Requirements /h3 ul liStrong ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats. /li liExpertise in pharmacovigilance processes, including safety signal management, aggregate report authoring, and regulatory compliance. /li liSolid understanding of global clinical trial and post‑marketing safety regulations. /li liProficiency in data processing tools such as Excel, PowerPoint, and Word, as well as familiarity with safety database systems. /li liDemonstrated leadership and collaboration skills within cross‑functional teams. /li liStrong organizational abilities, with the capacity to prioritize tasks independently. /li liEducational background in biological or natural sciences, health disciplines, or an advanced degree (e.g., PhD, MPH, NP, PharmD). /li liExperience in pharmacovigilance, particularly in aggregate safety reporting and signal management. /li /ul pIf you are having difficulty in applying or if you have any questions, please contact bOlivier Worch /b at. /p h3Apply Now /h3 pIf you are interested in applying to this exciting opportunity, click the “Apply” button or request a call back to speak with one of our specialists. /p /p #J-18808-Ljbffr