| Drug Safety Assessment Manager |
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| Also referred to as: Drug Safety Assessment Manager, Drug Safety Monitoring and Information Manager, Drug Safety/Medical Information Manager |
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| Requirements and Responsibilities |
| Manages drug safety assessment programs and pharmacovigilance operations to ensure effective monitoring, evaluation, and reporting of product safety information across the organization. Directs adverse event processing, case review, aggregate reporting, and safety surveillance activities in compliance with global regulatory requirements and company policies. Develops and implements pharmacovigilance procedures, quality controls, and workflow improvements to enhance operational performance and regulatory readiness. Evaluates safety trends, signals, and risk data to support benefit-risk assessments and product safety strategies. Collaborates with clinical development, regulatory affairs, medical affairs, and quality teams to support product lifecycle safety management and regulatory submissions. Leads staff development, resource planning, vendor oversight, and audit preparation activities within the drug safety function. Requires a bachelor's degree. Typically reports to a director. Manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. |
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| Similar Jobs: Drug Safety Assessment Manager, Sr., Drug Safety Assessment Specialist III, Drug Safety Assessment Specialist II, Drug Safety Assessment Director, Drug Safety Assessment Supervisor, VP of Drug Safety Assessment, Drug Safety Assessment Specialist I, Drug Safety Assessment Specialist IV, Drug Safety Assessment Specialist V |
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| Level of Education: Drug Safety Assessment Manager Salaries with No Diploma, Drug Safety Assessment Manager Salaries with a High School Diploma or Technical Certificate, Drug Safety Assessment Manager Salaries with an Associate's Degree, Drug Safety Assessment Manager Salaries with a Bachelor's Degree, Drug Safety Assessment Manager Salaries with a Master's Degree or MBA, Drug Safety Assessment Manager Salaries with a JD, MD, PhD or Equivalent |
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| Industries: Biotechnology, Edu., Gov't. & Nonprofit, Healthcare, Pharmaceuticals | |
