Pharmacovigilance Manager

Bausch Health Companies is a global diversified pharmaceutical company dedicated to delivering better health outcomes through our relentless drive to innovate and improve. Our company is built on a foundation of shared values, including a commitment to excellence, unity, and a sense of urgency to make a positive impact on people's lives.

We are seeking a highly skilled and experienced Pharmacovigilance Manager to join our Global Pharmacovigilance and Risk Management team. As a key member of our team, you will be responsible for conducting signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Your expertise will be crucial in identifying potential signals, validating, and preparing signal assessment reports or other related documents.

• Conduct signal detection and analysis activities to ensure safety signals are appropriately managed and tracked.
• Identify potential signals, validate, and prepare signal assessment reports or other related documents.
• Assist in aggregate safety data review.
• Participate in the preparation of CCSI/CCDS.
• Coordinate/co-author the finalization of documents such as RMPs/REMS, PSURs, and DSURs.
• Prepare responses to ad-hoc requests from regulatory agencies.
• Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines.
• Develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
• 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.

• Higher level of education/qualification in life science discipline or relevant experience, preferably medicine, pharmacy, or veterinary degree.
• Relevant pharmacovigilance experience (3-5 years) including signal detection.
• 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).
• Knowledge of statistical software and use of drug safety database.
• Ability to work under pressure to meet tight deadlines.
• Ability to manage complex tasks in a matrix environment.
• Strong organizational skills, detail-oriented, ability to adapt in a fast-paced constantly changing environment.
• Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat).
• Excellent communication skills and ability to work within the team and cross-functionally.
• Fluency in English.

• Working in a global position.
• Pleasant working atmosphere in an international environment.
• Opportunity for learning and growing in a positive and supportive team of professionals.