PV Project Manager and Deputy QPPV – Mendrisio site (Ticino)

ppFounded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address further healthcare needs. /p h3Position Summary /h3 pThe Pharmacovigilance (PV) Project Manager and Deputy QPPV will report directly to the Corporate Drug Safety Manager, QPPV Vigilance MD Responsible Person, playing a strategic role in supporting the oversight, maintenance, and continuous improvement of the global Pharmacovigilance system, ensuring full compliance with applicable Swiss, EU and international regulations. /p h3Key Responsibilities /h3 ul liLead and coordinate Pharmacovigilance projects, ensuring timely delivery and alignment with business and regulatory requirements. /li liAct as Deputy QPPV, ensuring continuity of Pharmacovigilance operations, regulatory compliance, and appropriate oversight during periods of QPPV absence. /li liOversee global Pharmacovigilance system activities, ensuring compliance with Swiss, EU, and international regulations. /li liSupport the maintenance of Swiss and Global Pharmacovigilance System Master File (PSMF), coordinating input from internal functions and external partners. /li liLead signal management activities and contribute to the benefit-risk evaluation of company’s products. /li liCoordinate safety communications including Direct Healthcare Professional Communications (DHPCs). /li liOversee the preparation and submission of aggregate safety reports (PSUR/PBRER, DSUR). /li liEnsure end-to-end oversight of adverse event collection, assessment and reporting from all sources (spontaneous reports, clinical trials, literature, partners). /li liMaintain strong collaboration with the affiliate, commercial partners and external vendors to ensure global PV compliance. /li liOversee the Global Safety Database and support system maintenance, upgrades and configuration activities. /li liMonitor regulatory intelligence and ensure compliance with EudraVigilance and other applicable reporting requirements. /li liSupport the development, review, and maintenance of SOPs and controlled PV documentation. /li liEnsure inspection readiness and contribute to continuous improvement of the PV system across the product lifecycle (pre- and post-authorization activities). /li /ul h3Qualifications And Skills /h3 ul liMaster’s degree or PhD in a scientific or healthcare discipline (e.g. Pharmacy, Medicine, Biology, Chemistry or related field). /li liAt least 5–8 years of experience in Pharmacovigilance within a pharmaceutical company or CRO. /li liStrong knowledge of EU GVP modules, ICH guidelines, Swiss and global PV regulations. /li liPrevious experience as Deputy QPPV or in a senior PV role is strongly preferred. /li liExperience with signal management, aggregate reporting, PSMF, and safety databases (e.g. Veeva Vault Safety). /li liSolid experience in PV project management and cross-functional coordination. /li liExcellent command of written and spoken Italian and English; French is a plus. /li liFamiliarity with regulatory inspections and compliance processes is an advantage. /li /ul pPreference will be given to candidates based in Switzerland. /p h3We Offer /h3 pFulltime permanent employment in a dynamic and scientifically driven working environment. /p pSintetica promotes diversity and gender equality. /p /p #J-18808-Ljbffr