Drug Safety Public Health Specialist - II

Posted 9 days ago

infotree global solutionsSan Mateo (CA)

Health Information Technologists and Medical Registrars Pharmaceutical Preparation Manufacturing

SENIORITY

Senior

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About the role

Job TitleYou will perform daily coding in accordance with company coding conventions. You will also perform periodic coding reviews and respond to coding-related queries from other functions, e.g., Safety Operations, Clinical Data Science, etc. You will complete training on all core coding activities and develop knowledge of good pharmacovigilance (GVP), regulations, data retrieval and processing, clinical trials, and good clinical practices (GCP).

Job Responsibilities:

Performs standard or routine medical coding that enables CS to meet its commitments.
Applies good analytical skills and strong attention to detail to alert others on any potential medical coding issues.
Codes Adverse Event (AE) and medical history (MH) terms with MedDRA Dictionary, and medication terms (CM) with WHODrug in accordance with Gilead coding conventions.
Collaborates with Clinical Data Management (CDM) and other groups within Clinical Data Science (CDS) to ensure timely completion of coding jobs and reviews.
Responds to coding-related questions in a timely manner.
Performs AE consistency reviews.
Identifies coding issues and proactively proposes possible solutions to CS Leadership.
May collaborate with other MSS staff to create search term lists in a timely manner and with senior CS team member guidance.
May collaborate on CS-internal projects.
Assists with additional activities in order to support the CS group e.g. taking meeting minutes.
Participates in the Core Coding Committee (CCC) meetings.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements. Required Qualification
U.S.

Education & Experience:

MA/MS/MBA with 2+ years' relevant experience.
BA/BS/BSN with 4+ years' relevant experience.
Coding experience using MedDRA and/or WHODrug is preferred.
BA/ BS or advanced degree in life sciences or related field with some experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environments. Nursing or PharmD is preferred. Knowledge & Other Requirements
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of GCP and GVP is preferred.
Knowledge of MedDRA and WHODrug dictionaries and medical coding applications / uses is preferred.
Demonstrates strong attention to detail and good analytical skills.
Demonstrates strong proficiencies in the Client Office suite.
Ability to communicate in a clear and concise manner.
Ability to support a team-oriented, highly-matrixed environment.
Ability to execute multiple tasks as assigned.

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