Which role is primarily responsible for ongoing pharmacovigilance and adverse event reporting within a pharmaceutical company?

Which role is primarily responsible for ongoing pharmacovigilance and adverse event reporting within a pharmaceutical company?

• A. Medical affairs team
• B. Regulatory affairs team
• C. Compliance team
• D. Pharmacovigilance team

Answer: (D)

Ongoing pharmacovigilance is about continuous safety surveillance of a drug, including collecting, evaluating, and reporting adverse events to regulators in a timely manner. The team specialized in pharmacovigilance handles case processing (assignment of seriousness, causal assessment, coding in safety databases), maintains safety data across the product lifecycle, and compiles regulatory safety reports such as expedited adverse event submissions and periodic safety update reports. This function is built to detect safety signals, manage risk, and ensure compliance with pharmacovigilance requirements worldwide. Medical affairs focuses on scientific communications and medical information to healthcare professionals and patients. Regulatory affairs coordinates interactions with authorities and submissions, ensuring regulatory compliance and proper approvals. Compliance oversees adherence to internal policies and external laws. While these roles interact with safety data, the continuous safety monitoring and adverse event reporting responsibilities reside with the pharmacovigilance team.

Ongoing pharmacovigilance is about continuous safety surveillance of a drug, including collecting, evaluating, and reporting adverse events to regulators in a timely manner. The team specialized in pharmacovigilance handles case processing (assignment of seriousness, causal assessment, coding in safety databases), maintains safety data across the product lifecycle, and compiles regulatory safety reports such as expedited adverse event submissions and periodic safety update reports. This function is built to detect safety signals, manage risk, and ensure compliance with pharmacovigilance requirements worldwide.

Medical affairs focuses on scientific communications and medical information to healthcare professionals and patients. Regulatory affairs coordinates interactions with authorities and submissions, ensuring regulatory compliance and proper approvals. Compliance oversees adherence to internal policies and external laws. While these roles interact with safety data, the continuous safety monitoring and adverse event reporting responsibilities reside with the pharmacovigilance team.