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Associate Manager, Coding Management (CM) - Drug Safety & Public Health (DSPH) - Grade 28
• Ensures accurate coding of adverse event with MedDRA and medication terms with WHO Drug Dictionary for clinical and post-marketing data in accordance with Client conventions.
• Collaborates with Clinical Data Management (CDM) to ensure timely completion of coding jobs and reviews.
• Collaborates on special projects as needed, and with other Client staff to identify adverse event signals and trends.
• Contributes to the development and maintenance of Client coding conventions.
• Mentors junior staff to ensure competence in pharmacovigilance and coding skills and knowledge.
Essential Duties and Job Functions:
• Contributes as a member of the Core Coding Committee (CCC).
• Demonstrates an ability to complete coding, solve coding problems independently and suggest process improvements.
• Demonstrates effectiveness in cooperation and teamwork, judgment and problem solving, and planning and information seeking skills.
• Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.
• Demonstrates knowledge and application of biopharmaceutical industry standards and practices.
• Demonstrates proficiency in verbal and written communication, including the use of Microsoft Excel, Word, and Power Point.
• Demonstrates proficient ability to perform medical coding using MedDRA and WHO Drug Dictionary and solid knowledge of medical terminology and medications.
• Develops knowledge of pharmacovigilance, regulations, data management, data retrieval, clinical trials, and clinical development commensurate with level.
• Develops solutions to moderately complex problems, and refers to established precedents and policies, or uses original thinking.
• Exerts influence toward the overall objectives and long-range goals of the organization.
• May participate on cross-functional teams, and may represent group as a prime contact on projects.
• May represent organization as a prime contact on projects, and interact with internal and external personnel on significant matters often requiring coordination between organizations.
• May train end users on coding dictionaries, conventions, and tools.
• Participates in determining objectives of assignments, plans, schedules, and arranges own activities in accomplishing objectives; work is reviewed periodically for adequacy in meeting objectives.
• Provides input and supports team objectives, priority projects and long-range goals of the department.
• Recognizes and seeks interdepartmental assistance for missing data.
• Works under some supervisory direction.
Knowledge, Experience and Skills:
• Requires a degree in health sciences (e.g., nursing, pharmacy or other related medical field) or professional qualification in a relevant scientific/technical discipline.
• Related experience in the biopharmaceutical industry, clinical research or other healthcare field is preferred.
o 5-6 years with BS, BA
o 4+ years with MS, MA
o 0+ year with MD, PharmD, PhD or equivalent
• Related experience in life sciences or pharmaceutical industry may be equivalent substitution for education.
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