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. /p pAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity 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. /p h3Chiesi Research Development /h3 pOur 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). /p h3Who we are looking for /h3 h3This is what you will do /h3 pPlay a key role in safeguarding patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi’s global portfolio. You will ensure the quality, compliance, and integrity of safety data, collaborate with international stakeholders, and drive continuous improvement, inspection readiness, and operational excellence across global Patient Safety processes. /p h3You will be responsible for /h3 ul liSupport the GRAPS Safety Operations PM Head in ensuring that all current requirements for these activities are effectively incorporated into Chiesi processes and documented in procedures /li liEnsure data collection in alignment with the safety strategy for Chiesi products, from any possible source, assessment and delivery of high-quality postmarketing safety data in a timely manner, ensuring that it is correct, consistent (including reconciled),



compliant and delivered to agencies /li liProvide oversight of the evaluation of scientific literature at both global and local level to identify case safety reports /li liProvide oversight of Company sponsored controlled websites/Apps and other social media /li liActively engage applicable customers, affiliates and other stakeholders /li liParticipate to interdepartmental meetings inside and outside RD /li liAct as the primary source of subject-matter expertise to address any questions from Chiesi staff or from external contacts regarding these activities and processes, being responsible for implementing requirements, trainings, procedures maintenance and vendor oversight /li liGuarantee data reconciliations with affiliates and contractual partners /li liProvide appropriate training of relevant internal and vendor staff for these processes, as applicable /li liSupport the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs) /li liInteract with the Safety Science team for product-specific safety strategy data collection inputs /li liSupervise and/or review of PV operations-relevant sections of documents pertinent to ODCS with regards to PV topics/involvement (e.g. safety reporting requirements, PV clauses in contracts, reconciliations, vendor selection) including set-up of electronic AE/ADR reporting /li liOversee PV operations activities with concerned Contract Research Organizations (CROs), including reconciliation activities; supervising PV agreements with CROs /li liEnsure data related to each process under the area of competency of PM PV OPS team are properly filled out in the PSMF /li liOpen deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation /li liFor all GVP audits and inspections, serve as the expert for activities under the role, Pre-work in preparation for the audit/inspection, Direct interviews with auditors/inspectors, as required, and Follow-up on any subsequent actions and CAPAs /li liActively participate in process improvement activities within the GRAPS department /li liMaintain compliance with relevant regulations, policies and procedures /li /ul h3You will need to have /h3 ul liDegree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline. /li liSolid experience in Pharmacovigilance Operations within a pharmaceutical, biotechnology, or healthcare environment. /li liStrong knowledge of global pharmacovigilance regulations, GVP requirements, and post-marketing safety processes. /li liExperience managing safety data collection activities and ensuring data quality, compliance, and timely reporting.



/li liDemonstrated ability to work effectively with cross-functional and international stakeholders. /li liExcellent communication, influencing, and stakeholder engagement skills. /li liExperience working with external vendors and service providers, ensuring effective oversight and compliance. /li liStrong analytical, problem-solving, and continuous improvement mindset. /li liExperience supporting audits, inspections, or compliance-related activities in a regulated environment. /li liProfessional proficiency in English, both written and spoken. /li /ul h3We would prefer for you to have /h3 ul liAdvanced knowledge of post-marketing safety data collection channels, mainly of ODCS and literature monitoring. /li liExperience with medical device and combination product vigilance activities. /li liExperience managing pharmacovigilance activities in a global and matrix organization. /li liKnowledge of safety agreements, vendor governance, and CRO oversight. /li liExperience with pharmacovigilance quality systems, deviations, CAPAs, and inspection readiness programs. /li liFamiliarity with Pharmacovigilance Service Providers and outsourced operating models. /li liExperience delivering training and driving process implementation across global teams. /li liKnowledge of safety databases, digital PV solutions, and emerging technologies supporting PV operations. /li liProject management or change management experience in a regulated environment. /li /ul h3Location /h3 pThe position is based at our headquarters in Parma and offers a flexible hybrid working arrangements. /p h3Compensation range /h3 pThe 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. /p h3What we offer /h3 ul liWe provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. /li liThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /li liIn addition, we offer a comprehensive benefits package including, pension, private medical insurance, wellbeing programme, flexible benefits programme and more /li /ul pChiesi 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. /p /p #J-18808-Ljbffr

📌 GRAPS Patient Safety Operations, Post Marketing Manager (Parma)
🏢 Chiesi Group
📍 Parma