Safety Risk Manager
hace 3 semanas
We 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 Analysis: Conduct thorough signal detection and analysis activities to identify potential safety signals and ensure they are appropriately managed and tracked.
- Signal Validation and Reporting: Validate and prepare signal assessment reports, or other related documents, to support regulatory submissions and compliance.
- Data Analysis and Review: Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals.
- Aggregate Safety Data Review: Assist in the review of aggregate safety data to ensure compliance with regulatory requirements.
- Regulatory Document Preparation: Participate in the preparation of CCSI/CCDS, RMPs/REMS, PSURs, and DSURs.
- Regulatory Agency Communication: Prepare responses to ad-hoc requests from regulatory agencies.
- Pharmacovigilance Expertise: Maintain expertise in pharmacovigilance, 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 Experience: 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 (post-marketing regulations preferred).
- Technical Skills: Knowledge of statistical software and use of drug safety database.
- Personal Qualities: Ability to work under pressure to meet tight deadlines, ability to manage complex tasks in a matrix environment.
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Global Risk Management Specialist
hace 3 semanas
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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Global Risk Management Specialist
hace 3 semanas
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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Pharmacovigilance Manager
hace 7 días
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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Pharmacovigilance Manager
hace 7 días
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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Pharmacovigilance Manager
hace 3 semanas
Pontevedra, Pontevedra, España Bausch Health Companies A tiempo completoJob SummaryWe 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 ResponsibilitiesSignal Detection and Analysis: Conduct thorough signal detection...
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Pharmacovigilance Manager
hace 3 semanas
Pontevedra, Pontevedra, España Bausch Health Companies A tiempo completoJob SummaryWe 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 ResponsibilitiesSignal Detection and Analysis: Conduct thorough signal detection...
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Operations Manager
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