R&D GRAPS Affiliate and Partnership Oversight Unit Head
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AI Summary
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
Assure that relationship with Partners and Affiliates are duly managed in the light of patient safety related matters 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 enable timely identification of contracts requiring SDEA development
- Act the main point of contact for matters relating to SDEAs, Intracompany Agreements, and/or license partners providing advice and guidance on contracts generation in collaboration with the Head of Affiliate Network
- On-going interface 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 all SDEAs are kept current 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 related fields
- Minimum 5/7 years of experience in international Pharmacovigilance within Pharmaceutical and/or Biotechnology industry and/or Contract Research Organisation
- Excellent communication, interpersonal, negotiation and leadership skills
- Proven ability to manage contracts and keep 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 achieve 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 range
The minimum salary for this role is €62.000, aligned to our established salary framework. 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.
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.
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