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Ontario Drug Safety Assessment Manager, Sr. Salaries

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• Job Description for Drug Safety Assessment Manager, Sr.
  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. Typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments.

  Alternate Job Titles: Drug Safety Monitoring and Information Manager, Sr.,Drug Safety/Medical Information Manager, Sr.
  Categories: Pharmaceuticals , Biotechnology , Healthcare - Practitioners , Science and Research