Clinical Safety Lead

4 weeks ago


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

We are seeking a highly skilled Clinical Safety Scientist to lead our safety surveillance and risk management efforts for a large, late-stage program or multiple early-stage programs. The ideal candidate will have a strong background in clinical development and safety risk management, with experience in proactively identifying and mitigating safety risks.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and implement safety strategies and risk management plans
  • Lead the coordination of Safety Management Team (SMT) meetings and maintain records of discussions and decisions
  • Evaluate safety data to identify potential safety signals and perform safety analysis and evaluation
  • Develop and communicate safety action recommendations and risk minimization plans to stakeholders
  • Oversee the tracking of safety signals in global electronic signal tracking tools
  • Collaborate with Product Safety Leads and Clinical Safety Physicians to plan and prioritize activities for Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs)
Requirements
  • Advanced degree in a relevant field (e.g. pharmacology, toxicology, epidemiology) and 3-5 years of experience, or a bachelor's degree and 6-9 years of experience
  • Proven experience in clinical development and safety risk management, with a strong understanding of safety regulations and guidelines
  • Excellent communication and interpersonal skills, with the ability to work effectively in a matrixed environment
  • Ability to develop and build healthy working relationships to enable higher performance
  • Effective oral and written communication skills, with the ability to present complex information to stakeholders


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