Clinical Safety Scientist Lead

9 hours ago


Basking Ridge, New Jersey, United States Planet Pharma Full time
Job Summary

We are seeking a highly skilled Clinical Safety Scientist Lead to join our team at Planet Pharma. As a key member of our safety team, you will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.

Key Responsibilities
  • Collaborate with Product Safety Leads to plan and prioritize safety surveillance and risk management activities for assigned products.
  • Oversee the coordination of Safety Management Team (SMT)/Product-level safety meetings, maintain roster, calendar, and minutes, and communicate materials.
  • Independently evaluate safety data to identify potential safety signals and perform safety analysis/evaluation.
  • Contribute to safety action recommendations, communication, and risk minimization plans.
  • Present assessments to appropriate forums, including SMT or other cross-functional teams.
  • Track safety signals in the global electronic signal tracking tool.
  • Collaborate with Product Safety Leads to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country submissions.
  • Develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD).
Requirements
  • 3-5 years of proven experience with an advanced degree required.
  • 6-9 years of experience with a bachelor's degree required.
  • Subject matter expert (SME) in 2 or more focus areas.
  • Effective oral and written communication skills.
  • Ability to handle multiple complex projects simultaneously, prioritizing and recognizing key issues.
  • Microsoft Word, Excel, PowerPoint skills, and Project management skills.


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