Must have at least 1 year of prior work experience in each of the followingbr 1. Performing drug safety and pharmacovigilance PV related activities to identify adverse event information to assess the validity of Individual Case Safety Reports ICSRs.br 2. Using drug safety database Argus or Aris G to process Individual Case Safety Reports ICSRs to ensure accurate and consistent data entry from source documents originating from clinical and postmarketing studies.br 3. Processing adverse event information in a drug safety database, including medical conditions, lab results, and procedures.br 4. Using MedDRA to perform coding of adverse events, medical history, procedures, indications, and laboratory tests.br 5. Using the WHO Drug Dictionary to perform coding of concomitant and treatment medications in a drug safety database.br 6. Applying domestic and international drug safety regulations, industry practices, and standards to identify adverse events, assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information.br Some telecommuting permitted.
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