ppDescrizione dell'offerta di lavoro /p h3About us /h3 pChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.
/p pLa preghiamo di verificare di possedere il livello di esperienza e le qualifiche adeguate leggendo la panoramica completa di questa opportunità qui sotto.
/p pMore than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.
/p pThis is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
/p pDiscover more here.
/p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
/p pThis fosters a culture of reliability, transparency, and ethical behaviour at every level.
/p pAs a Benefit 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.
/p pWe believe our differences make us stronger.
/p pWe 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.
/p pIt 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.
/p pHeadquartered 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 pTo ensure that the pharmacovigilance quality system, implemented at the corporate and affiliate levels, complies with applicable regulatory requirements and company quality standards.

/p h3Responsibilities /h3 ul liManage pharmacovigilance deviations identified through compliance monitoring /li liMonitor the implementation of CAPAs resulting from audits and deviations /li liInform the QPPV of the status of non?conformities identified through compliance monitoring /li liReview the PV System's SOPs/WIs to ensure compliance with applicable pharmacovigilance regulations and internal quality standards /li liDraft SOPs/WIs related to pharmacovigilance quality assurance activities /li liSupport the preparation, management, and follow?up of inspections/audits by regulatory authorities and partners /li liCollaborate on data collection and the development of metrics/KPIs related to the PV QMS /li liManage and support the changes applicable to the PV System /li liCollaborate on updating and review the PSMF with information related to the PV QMSS /li liSupport the maintenance of the qualification status of pharmacovigilance suppliers within company systems /li liUpdate and maintain company systems and tools used for PV QMS management, in accordance with regulatory requirements and company standards /li /ul h3Qualifications /h3 ul liDegree in Life Sciences (Pharmacy, Biology, Medicine, Biotechnology, Chemistry or equivalent) /li li3–5 years in pharmacovigilance and/or QA in pharma /li liHands?on experience with: PV QMS (deviations, CAPA, change control) /li liSOP/WI writing and review /li liStrong knowledge of GVP / PV regulations (EMA/FDA) /li liUnderstanding of PSMF and PV systems /li liExperience with quality systems and PV tools/databases /li liAbility to manage compliance monitoring and metrics/KPIs /li liStrong communication with stakeholders incl.
QPPV interface /li liEnglish fluent /li liExperience in global/matrix pharma environment /li liExposure to regulatory inspections (EMA/FDA)

/li liAudit/inspection support /li liSupplier qualification in PV /li liKnowledge of ICH guidelines /li /ul h3Location /h3 pThe position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options.
/p h3Compensation range /h3 pThe minimum salary for this role is ******, aligned to our established salary framework.
/p pThe final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.
/p pThis role is eligible to participate in an annual premio scheme, subject to company and individual performance.
/p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.
/p h3What we offer /h3 pNo matter where your path starts at Chiesi, it leads to inspiring possibilities.
/p pYour 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.
/p pWe provide top?class benefits, including comprehensive healthcare programs, work?life balance initiatives, and robust relocation support.
/p pOur salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
/p pAdditionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
/p h3Equal opportunities / DEI /h3 pChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business.
/p pAll 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.
/p pThis policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
/p /p #J-*****-Ljbffr

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