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Global Pharmacovigilance Operations Manager: Spearheading Regulatory Compliance
1 mese fa
We are seeking a highly skilled Global Pharmacovigilance Operations Manager to join our team. As a key member of our R&D department, you will play a crucial role in ensuring the successful execution and oversight of pharmacovigilance operations activities within our Air Business Unit.
Main Responsibilities- Collaborate with the Global PV Operations Unit Head, Air, in planning GPV Ops activities on specific projects within the AIR business area
- Provide input within the AIR Business Unit to ensure seamless integration of pharmacovigilance operations
- Manage studies, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies included), reviewing/drafting relevant documents
- Monitor PV operations activities of CROs involved in clinical studies to ensure compliance with regulatory requirements
- Assist the Integration Manager in the integration phase of company/products acquisition as well as during due diligences
- Manage projects that foresee a collaboration model with other companies in a Global exclusive license agreement, setting up processes and exercising the oversight on their activities
- Participate as a member to regulatory submission teams to ensure timely and accurate submissions
- Contribute to the development of global SOPs and WIs and other controlled documents
- Support other PV activities, both at global and affiliate level
- Be responsible for cross-functional projects and processes
- Participate in audit and inspection activities to ensure compliance with regulatory requirements
- Minimum 7 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years of experience in Pharmacovigilance
- Master degree in science, medicine, biology, pharmacy or related fields
- Fluent English
- Awareness of EU pharmacovigilance legislation
- Technical writing capability
- Up-to-date knowledge of clinical trial requirements
We offer a competitive salary range of $120,000 - $160,000 per annum, depending on your experience and qualifications. Additionally, we provide a dynamic and fast-growing work environment, flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.
OthersThis is a fantastic opportunity to join a leading pharmaceutical company and contribute to the success of our Air Business Unit. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
