GRAPS Patient Safety Operations, Post Marketing Specialist

Job description

About us Chiesi 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. At 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. Diversity 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. Chiesi Research & Development Our R&D 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, R&D 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). Who we are looking for This is what you will do Play 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. You will be responsible for • Support 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 • Ensure 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 • Provide oversight of the evaluation of scientific literature at both global and local level to identify case safety reports • Provide oversight of Company sponsored controlled websites/Apps and other social media • Actively engage applicable customers, affiliates and other stakeholders • Participate to interdepartmental meetings inside and outside R&D • Act 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 • Guarantee data reconciliations with affiliates and contractual partners • Provide appropriate training of relevant internal and vendor staff for these processes, as applicable • Support the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs) • Interact with the Safety Science team for product-specific safety strategy data collection inputs • Supervise 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 • Oversee PV operations activities with concerned Contract Research Organizations (CROs), including reconciliation activities; supervising PV agreements with CROs • Ensure data related to each process under the area of competency of PM PV OPS team are properly filled out in the PSMF • Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation • For 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 • Actively participate in process improvement activities within the GRAPS department • Maintain compliance with relevant regulations, policies and procedures You will need to have Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline. Solid experience in Pharmacovigilance Operations within a pharmaceutical, biotechnology, or healthcare environment. Strong knowledge of global pharmacovigilance regulations, GVP requirements, and post-marketing safety processes. Experience managing safety data collection activities and ensuring data quality, compliance, and timely reporting. Demonstrated ability to work effectively with cross-functional and international stakeholders. Excellent communication, influencing, and stakeholder engagement skills. Experience working with external vendors and service providers, ensuring effective oversight and compliance. Strong analytical, problem-solving, and continuous improvement mindset. Experience supporting audits, inspections, or compliance-related activities in a regulated environment. Professional proficiency in English, both written and spoken. We would prefer for you to have Advanced knowledge of post-marketing safety data collection channels, mainly of ODCS and literature monitoring. Experience with medical device and combination product vigilance activities. Experience managing pharmacovigilance activities in a global and matrix organization. Knowledge of safety agreements, vendor governance, and CRO oversight. Experience with pharmacovigilance quality systems, deviations, CAPAs, and inspection readiness programs. Familiarity with Pharmacovigilance Service Providers and outsourced operating models. Experience delivering training and driving process implementation across global teams. Knowledge of safety databases, digital PV solutions, and emerging technologies supporting PV operations. Project management or change management experience in a regulated environment. Location The position is based at our headquarters in Parma and offers a flexible hybrid working arrangements. Compensation range The budgeted salary range approved for this role is between €46.000 and €57.500. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including , pension, private medical insurance, wellbeing programme, flexible benefits programme and more What we offer No 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. We 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. Chiesi 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.