Global Risk Management Specialist

hace 3 semanas


Pontevedra, Pontevedra, España Bausch Health Companies A tiempo completo
Job Description

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:
  1. Signal Detection and Analysis: Conduct thorough signal detection and analysis activities to identify potential safety issues and ensure that safety signals are appropriately managed and tracked.
  2. Signal Validation and Reporting: Validate and prepare signal assessment reports, or other related documents, to support regulatory submissions and internal decision-making.
  3. Data Analysis and Mining: Contribute to analyses in external databases (e.g. EVDAS) using data mining methods for detection and evaluation of safety signals.
  4. Aggregate Safety Data Review: Assist in the review of aggregate safety data to identify trends and patterns.
  5. Regulatory Document Preparation: Participate in the preparation of CCSI/CCDS, RMPs/REMS, PSURs, and DSURs.
  6. Regulatory Agency Communication: Prepare responses to ad-hoc requests from regulatory agencies.
  7. Pharmacovigilance Expertise: Maintain expertise in pharmacovigilance, including understanding of international safety regulations and guidelines.
  8. 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.
  9. 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.
Requirements:
  1. Education and Experience: 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.
  2. 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). Knowledge of statistical software and use of drug safety database.
  3. Personal Qualities: Ability to work under pressure to meet tight deadlines. Ability to manage complex tasks in a matrix environment.

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