Adverse Reaction Management

  • Receiving, recording, MedDRA coding, medical assessment, follow-up actions and duplication control of adverse reactions from spontaneous reports and quality complaints.
  • Management of serious adverse reactions from clinical trials.
  • Reporting all local adverse reactions to global/licensor, if necessary.
  • Reporting all suspected serious adverse reactions to the authorities
  • Archiving of all adverse reactions
  • Following up and reflecting in PBRERs of all adverse reactions received from global/licensor and other countries
  • Management of Medical Queries
    • Management of medical queries from consumers/HCPs/represents, following up adverse reactions from medical queries and reflecting them in PBRERs
    • Management of medical queries received during non-working hours.