Global Pharmacovigilance Operations Lead for Innovative Therapies

4 ore fa


Parma, Emilia-Romagna, Italia Chiesi A tempo pieno
About Us

Chiesi, an international pharmaceutical and healthcare group based in Parma, Italy, is renowned for its research-driven approach. With over 85 years of experience and operations in 31 countries, the company employs more than 7,000 individuals worldwide.

The Role

We are seeking a skilled Global Pharmacovigilance Operations Manager to support the Global Pharmacovigilance Team within the Research and Development department. This individual will be responsible for executing and overseeing pharmacovigilance operations activities within the 'Air' Business Unit.

Main Responsibilities
  • Collaborate with the Global PV Operations Unit Head to plan GPV Ops activities on specific projects within the AIR business area.
  • Provide input within the AIR Business Unit and manage studies, organized data collections, and Compassionate use/expanded access programs.
  • Monitor PV operations activities of CROs involved in clinical studies and provide assistance to the Integration Manager during due diligences and company/product acquisition integration phases.
  • Manage projects that foresee a collaboration model with other companies in a Global exclusive license agreement, setting up processes and exercising oversight on their activities.
  • Participate as a member in regulatory submission teams and provide inputs on global SOPs and WIs.
Requirements
  • A minimum of 7 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance.
  • A Master's degree in science, medicine, biology, pharmacy, or related fields.
  • Fluent English and awareness of EU pharmacovigilance legislation.
  • Technical writing capability and up-to-date knowledge of clinical trial requirements.
About Chiesi

We offer a dynamic, fast-growing, challenging, and friendly environment where you can grow professionally and personally. Our commitment to continuous training and development ensures your skills stay up-to-date. We value work-life balance, providing flexible working arrangements, remote work options, relocation support, tax assistance, and people-care services to enhance your overall well-being.

In this role, you can expect a salary in the range of $120,000 - $180,000 per annum, depending on your experience and qualifications.



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