Role Description

Scientific > Drug Safety Specialist

Salary National Average

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68620.0000 77850.0000 87950.0000

Change from Previous Year:

+2%

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Short Description:

Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals. A Drug Safety Specialist is involved in drug safety management such as conducting clinical trials, medical supervision and keeping a check on all the applicable regulations and SOPs. May work with chief medical directors.

Duties / Responsibilities:

  • Provide medical and clinical guidance to managers before, throughout, and following clinical trials.
  • Maintain consistency of safety assessments.
  • Perform a variety of safety assessments.
  • Serve in cross-functional teams as a medical and scientific representative.
  • Ensure regulatory compliance and safety throughout trial.
  • Submit periodic reports to the Food and Drug Administration.
  • Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
  • Address labeling concerns and updates.
  • Interpret regulatory mandates.
  • Assist with internal and external drug safety audits
  • Create company data sheets.
  • Remediate any pharmacovigilance deficiencies found during regulatory or internal audits.
  • Act as medical expert during product development.
  • Ensure subject safety during clinical studies.
  • Establish and maintain consistency of safety assessments within the US and outside the US.
  • Identify the correct actions and facilitate, support and implement them as appropriate.
  • Review performance metric data and clarify inconsistencies and trends.

Skills / Requirements / Qualifications

  • Ability to keep meticulous records
  • Attention to detail
  • Excellent analytical and problem-solving skills
  • Ability to interact and communicate effectively with a wide range of people
  • A systematic approach to tasks
  • Excellent IT skills
  • Good interpretative skills
  • Team work
  • Good math skills

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 skill, knowledge, and experience are needed for these occupations. Many require more than five years of experience. For example, surgeons must complete four years of college and an additional five to seven years of specialized medical training to be able to do their job.
  • 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, and/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. Examples include pharmacists, lawyers, astronomers, biologists, clergy, neurologists, and veterinarians.
  • SVP Range:  (8.0 and above)

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