GRAPS Safety Operations, Clinical Trials Manager

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ppSelect how often (in days) to receive an alert: /ph3GRAPS Safety Operations, Clinical Trials Manager /h3pDate: 30 Jul 2026 /ppDepartment: Global Regulatory Affairs Patient Safety /ppBusiness Area: RD, Pharmacovigilance Regulatory Affairs /ppJob Type: Direct Employee /ppContract Type: Permanent /ppLocation: Parma, IT /ppbAbout us /b /ppChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. /ppAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /ppDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /ppbChiesi Research Development /b /ppOur RD team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, RD project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). /ppbWho we are looking for /b /ph3bThis is what you will do /b /h3ulliTo carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials (CT) sponsored either by GCD or GRD functions by maintaining up-to-date processes for safety-related aspects of interventional clinical trials,



to meet current and evolving PV legislation /li /ulh3bYou will be responsible for /b /h3ulliSupport the GRAPS Safety Operations CT Head in ensuring that all current PV requirements for interventional clinical trials are effectively incorporated into Chiesi processes and documented in procedures /liliEnsure strategic collection, assessment and delivery of high-quality clinical trial safety data in a timely manner, ensuring that it is correct, consistent, compliant and delivered to agencies /liliActively engage CT customers, affiliates and other stakeholders /liliParticipate in interdepartmental meetings inside and outside RD /liliAct as owner (i.e. subject matter expert) for specific processes under the area of competency of CT PV OPS Unit, responsible for implementing requirements, training, procedure maintenance, vendor oversight /liliProvide appropriate training of relevant internal and vendor staff for these processes, as applicable /liliSupport the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs) /liliInteract with the Safety Science team for product-specific safety strategy data collection inputs /liliSupervise and/or review of PV operations-relevant sections of documents pertinent to clinical trials with regards to PV topics/involvement /liliOversee PV operations activities with concerned Contract Research Organizations (CROs) /liliEnsure data related to each process under the area of competency of CT PV OPS team are properly filled out in the PSMF /liliOpen deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation /liliManage PV OPS activities throughout Post-Integration phases, for RD assets /liliFor all GVP and GCP audits and inspections, serve as the expert for activities under the role /liliActively participate in process improvement activities within the GRAPS department /liliMaintain compliance with relevant regulations, policies and procedures /li /ulh3bYou will need to have /b /h3ulliMaster degree in science, medicine, biology, pharmacy or related fields /liliMinimum 4 years of experience in RD within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance or Clinical Research. /liliWillingness to operate in a diverse, international environment. /liliExcellent communication and interpersonal skills /liliAbility to work with initiative and autonomy,



demonstrating determination in achieving goals and tackling daily challenges /liliProblem solving and decision making skills /liliPlanning and analytical skills /li /ulh3bWe would prefer for you to have /b /h3ulliAwareness of the principles of global pharmacovigilance requirements /liliAwareness of GCP requirements /liliKnowledge of MedDRA coding dictionary and its principles /li /ulh3bLocation /b /h3pThe position is based at our headquarters in Parma and offers a flexible hybrid working arrangement. /ph3bCompensation range /b /h3pThe minimum salary for this role is €46.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /ppThis role is eligible toparticipatein an annual premio scheme, subject to company and individual performance. /ppIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more /ppbWhat we offer /b /ppNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /ppWe provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /ppChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /ph3DISCOVER ALL OUR JOB OPPORTUNITIES /h3h3Screen readers cannot read the following searchable map. /h3pTo activate drag with keyboard, press Alt + Enter. Once in keyboard drag state, use the arrow keys to move the marker. To complete the drag, press the Enter key. To cancel, press Escape. 3 Jobs 2 Jobs 1 Job /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7991gt