Pharmacovigilance Manager
hace 3 semanas
We are seeking a highly skilled Pharmacovigilance Manager to join our team at Bausch Health Companies. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our products and managing risk associated with their use.
Key Responsibilities- Signal Detection and Analysis: Conduct thorough signal detection and analysis activities to identify potential safety issues and ensure they are appropriately managed and tracked.
- Signal Validation and Reporting: Validate and prepare signal assessment reports and other related documents to support regulatory submissions.
- Data Analysis and Review: Contribute to analyses in external databases using data mining methods to detect and evaluate safety signals.
- Aggregate Safety Data Review: Assist in reviewing aggregate safety data to identify trends and patterns.
- Regulatory Document Preparation: Participate in the preparation of CCSI/CCDS documents and coordinate/co-author finalization of documents such as RMPs/REMS, PSURs, and DSURs.
- Regulatory Agency Communication: Prepare responses to ad-hoc requests from regulatory agencies.
- Expertise and Knowledge Management: Maintain pharmacovigilance expertise and understanding of international safety regulations and guidelines.
- Process Development and Implementation: Develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
- Stakeholder Collaboration: Liaise with internal stakeholders, including members of Medical Affairs, Data Management, and Regulatory Affairs, in a matrix environment as needed for specific project needs/plans.
- Education and Qualifications: Higher level of education/qualification in life science discipline or relevant experience, preferably medicine, pharmacy, or veterinary degree.
- Pharmacovigilance Experience: Relevant pharmacovigilance experience (3-5 years) including signal detection.
- Knowledge and Skills: Thorough knowledge of signal detection and risk management, good planning and organizational skills, understanding of international pharmacovigilance regulations including GVP and requirements, knowledge of statistical software and use of drug safety database, ability to work under pressure to meet tight deadlines, and ability to manage complex tasks in a matrix environment.
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Pharmacovigilance Manager
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Pharmacovigilance Manager
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Pontevedra, Pontevedra, España Bausch Health Companies A tiempo completoPharmacovigilance ManagerWe are seeking a highly skilled Pharmacovigilance Manager to join our team at Bausch Health Companies. As a key member of our Pharmacovigilance department, you will be responsible for conducting signal detection and analysis activities to ensure the safe management and tracking of safety signals.Key Responsibilities:Conduct signal...
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Safety Risk Manager
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Pontevedra, Pontevedra, España Bausch Health Companies A tiempo completoJob DescriptionWe are seeking a highly skilled and experienced Pharmacovigilance Manager to join our team at Bausch Health Companies. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our products and maintaining compliance with international regulations.Key Responsibilities:Signal Detection and...
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[Y-594] | Manager, Pharmacovigilance
hace 3 semanas
Pontevedra, España Bausch Health Companies A tiempo completoJoin a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, and international pharmaceuticals. Our 7,000 employees share a...
