| Drug Safety Assessment Specialist II |
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| Also referred to as: Drug Safety Assessment Specialist II, Drug Safety Monitoring and Information Specialist II, Drug Safety/Medical Information Specialist II, Intermediate Drug Safety/Medical Information Specialist |
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| Requirements and Responsibilities |
| Supports drug safety assessment and medical information activities by evaluating adverse event reports, responding to medical inquiries, and ensuring compliance with pharmacovigilance regulations and company standards. Reviews, documents, and processes adverse event and product quality complaint reports to identify new, unknown, or changing risks associated with a drug or medicine. Evaluates drug safety data for completeness, accuracy, and potential signal detection activities in accordance with established procedures and regulatory timelines. Responds to medical information inquiries by providing accurate and scientifically supported product information to internal and external stakeholders. Maintains safety databases and prepares case narratives, summaries, and supporting documentation for regulatory submissions and internal review. Collaborates with cross-functional teams, including clinical, regulatory, quality, and medical affairs, to support product safety monitoring and risk management initiatives. Requires a bachelor's degree. Typically reports to a manager. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2-4 years of related experience. |
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| Similar Jobs: Drug Safety Assessment Specialist III, Drug Safety Assessment Manager, Drug Safety Assessment Manager, Sr., Drug Safety Assessment Specialist IV, Drug Safety Assessment Specialist I, Drug Safety Assessment Specialist V, Drug Safety Assessment Director, Drug Safety Assessment Supervisor, VP of Drug Safety Assessment |
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| Level of Education: Drug Safety Assessment Specialist II Salaries with a High School Diploma or Technical Certificate, Drug Safety Assessment Specialist II Salaries with an Associate's Degree, Drug Safety Assessment Specialist II Salaries with a Bachelor's Degree, Drug Safety Assessment Specialist II Salaries with a Master's Degree or MBA, Drug Safety Assessment Specialist II Salaries with a JD, MD, PhD or Equivalent |
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| Industries: Biotechnology, Edu., Gov't. & Nonprofit, Healthcare, Pharmaceuticals | |
