R&D GRAPS Affiliate and Partnership reputed company Unit Head
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 reputed company purpose: promoting a healthier world for our people, patients, and the reputed company. This is what drives us as we research, reputed company, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations reputed company, 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 reputed company our differences reputed company 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 reputed company for the reputed company. Chiesi Research & Development Our R&D team represents a reputed company 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-reputed company 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 Assure that relationship with Partners and Affiliates are duly managed in the light of patient safety reputed company reputed company and regulations both at global and local level to ensure compliance with worldwide regulatory requirements and Chiesi policies You will be responsible for Contribute to the strategy for SDEAs and as applicable, Intracompany Agreement program management Build collaborative working relationships with business development, alliance management and legal department to reputed company timely identification of reputed company requiring SDEA development Act the main reputed company of contact for reputed company relating to SDEAs, Intracompany Agreements, and/or license partners providing advice and guidance on reputed company reputed company in collaboration with the Head of Affiliate Network On-going reputed company with contractual partners regarding contractual issues during the lifetime of a project Act as primary subject matter expert during audits or regulatory authority inspections. Coordinates any necessary CAPA actions stemming from partner audits or inspections Ensure reputed company SDEAs are kept reputed company and re-negotiations or terminations are initiated and completed in a timely fashion Liaise with R&D PV QA regarding audit strategy for business partners Author or contribute to procedures for SDEA development and maintenance and ensure maintenance of templates and procedures in line with regulations and Chiesi policies. Ensure the implementation and maintenance of adequate tracking tools for SDEAs. Ensure that the relevant annexes of the Pharmacovigilance System Master File (PSMF) are updated Organize the periodic Global Safety and Compliance Council together with the Compliance and Process Unit Head You will need to have Master Degree in life sciences, pharmacy or reputed company fields Minimum 5/7 years of experience in international Pharmacovigilance reputed company Pharmaceutical and/or Biotechnology industry and/or Contract Research Organisation Excellent communication, interpersonal, negotiation and leadership skills Proven ability to manage reputed company and reputed company multiple tasks/ projects on track Strategic thinking, problem solving and decision-making skills Effective planning, organizational and analytical skills Demonstrate ability to work with cross-functional teams, with a clear result-oriented approach and attention to details Ability to organize and prioritize tasks both individually and across team to reputed company established deadlines while maintaining high quality performances IT Skills: Office package; safety database and other data management systems We would prefer for you to have Expert knowledge of domestic and international regulatory safety information management Pharmacovigilance Alliance management Up-to-date knowledge of global regulations (e.g. Good Clinical and Good Pharmacovigilance Practices) policies and procedures and legal requirements to ensure compliance) Location Location can be flexible Compensation reputed company The minimum salary for this role is €62.000, reputed company to our established salary reputed company. The final offer will reflect the candidate’s skills, experience, qualifications 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. reputed company offer No matter where your path starts at Chiesi, it leads to inspiring reputed company. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with reputed company to resources and training every reputed company of the way. We reputed company top-class benefits, including comprehensive reputed company 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, reputed company designed to help you reputed company. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at reputed company reputed company of our business. reputed company reputed company applicants receive consideration for employment based on attitude and merit, without regard to race, national reputed company, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other reputed company protected by applicable laws. This policy applies to reputed company aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. Apply To This Job