Role Description

Scientific > Drug Safety Specialist

Salary National Average

Low Medium High
60810.0000 77670.0000 96610.0000

Supply and Demand

Candidate Supply: 176 Job Openings: 0

0 50 100

More Difficult Less Difficult

Salary Variance

Enter City, State to view local salaries and candidate demand.

Short Description:

A Drug Safety Specialist is responsible for monitoring and evaluating the safety and efficacy of pharmaceutical products throughout their lifecycle. Their duties include analyzing adverse event reports, conducting safety assessments, and ensuring compliance with regulatory requirements and industry standards. Drug Safety Specialists collaborate with clinical teams and regulatory agencies to identify and mitigate risks associated with drug use, as well as prepare safety reports and documentation. Strong analytical skills, attention to detail, and a thorough understanding of pharmacovigilance practices are essential for success in this role, as they play a crucial part in protecting patient safety and ensuring the integrity of drug information.

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

  • Education: Bachelor’s degree in life sciences, pharmacology, pharmacy, nursing, or a related field is typically required; a master’s degree or higher is often preferred.
  • Experience: Prior experience in pharmacovigilance, drug safety, or clinical research, usually ranging from 2 to 5 years, depending on the level of the position.
  • Knowledge of Regulations: Strong understanding of regulatory requirements and guidelines related to drug safety and pharmacovigilance, including FDA, EMA, and ICH guidelines.
  • Analytical Skills: Excellent analytical and critical thinking skills to assess safety data, identify trends, and make informed decisions regarding drug safety issues.
  • Attention to Detail: High attention to detail to ensure accurate data entry, reporting, and compliance with regulatory requirements.
  • Communication Skills: Strong verbal and written communication skills for effectively conveying complex safety information to various stakeholders, including healthcare professionals and regulatory agencies.
  • Technical Proficiency: Proficiency in using pharmacovigilance databases and software, as well as familiarity with electronic health records (EHR) and data management systems.
  • Teamwork and Collaboration: Ability to work collaboratively in a team environment, often liaising with cross-functional teams, including clinical, regulatory, and medical affairs.

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)

Share Role Details

Return to job listings