Role Description

Scientific > Global Safety Scientist

Salary National Average

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115760.0000 133360.0000 169560.0000

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Short Description:

Global Safety Scientist supports the Global Safety Officer (GSO) and safety teams in monitoring the safety and risk management of pharmaceutical products throughout their lifecycle. This role involves conducting safety assessments, performing signal detection, and authoring safety reports for both pre- and post-market products. The Global Safety Scientist ensures compliance with safety regulations and contributes to the overall safety strategy under the supervision of senior safety professionals.

Duties / Responsibilities:

  • Perform routine signal detection activities using internal and external safety databases and literature for assigned products.
  • Continuously monitor safety data for pre- and post-market products, ensuring timely identification of potential safety risks.
  • Support the authoring and review of periodic safety assessment reports, including PBREs and DSURs.
  • Contribute to the development and updates of informed consent forms and Risk Management Plans (RMPs).
  • Work closely with clinical study teams and other cross-functional colleagues to ensure safety data is integrated into decision-making processes.
  • Prepare presentation slides summarizing safety cases for internal or external use.
  • Author or review safety documents as needed, ensuring clarity and compliance with regulatory standards.
  • Implement product-related safety decisions as designated by the Global Safety Officer or Therapeutic Area Head.

Skills / Requirements / Qualifications

  • Pharmacovigilance (PV) Experience: Prior experience in pharmacovigilance or drug safety, including signal detection, is essential.
  • Educational Background: BS degree with 4+ years, MS with 2+ years, or Doctorate with relevant pharmacovigilance/drug safety experience.
  • Technical Skills: Proficiency with Microsoft Word, PowerPoint, Excel, and familiarity with safety databases.
  • Analytical Skills: Strong critical thinking and analytical abilities to assess safety data and detect potential signals.
  • Regulatory Knowledge: Experience in authoring safety sections of periodic aggregate safety update reports such as PBREs and DSURs.
  • Communication Skills: Excellent written and verbal communication skills for preparing safety documents and collaborating with cross-functional teams.
  • Detail-Oriented: Meticulous attention to detail in monitoring safety data and authoring regulatory documents.
  • Team Collaboration: Ability to work effectively with Global Safety Officers, PV Scientists, and clinical study teams to support the safety of assigned products.

Job Zones

  • Title: Job Zone Five Extensive Preparation Needed
  • Education: Most of these occupations require graduate school. For example, they may require a master's degree, and some require a Ph.D., M.D., or J.D. (law degree).
  • Related Experience: Extensive skills, knowledge, and experience are needed for these occupations. Many require more than five years of experience. 
  • Job Training: Employees may need some on-the-job training, but most of these occupations assume that the person will already have the required skills, knowledge, work-related experience, or training.
  • Job Zone Examples: These occupations often involve coordinating, training, supervising, or managing the activities of others to accomplish goals. Very advanced communication and organizational skills are required. 
  • Specific Vocational Preparation in years: 4-7 years preparation (8.0 and above)

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