Virtual Employee Interview Questions and Answers

Expedited reporting timelines are critical for timely safety assessments in pharmacovigilance.

• Serious Adverse Events (SAEs) must be reported within 7 days to regulatory authorities.

• Non-serious events typically have a 15-day reporting timeline.

• For expedited reports, the clock starts from the date the company becomes aware of the event.

• Example: If a patient experiences a serious allergic reaction on January 1st and the company learns of it on January 5th, the report is due by J...read more

Documents submitted for approval include technical reports, clinical trial data, labeling, and manufacturing information.

• Technical reports

• Clinical trial data

• Labeling

• Manufacturing information

I have extensive experience in aggregate reporting within pharmacovigilance, ensuring compliance and safety monitoring.

• Conducted periodic safety update reports (PSURs) for multiple products, analyzing data trends.

• Collaborated with cross-functional teams to compile data for risk management plans.

• Utilized statistical software to assess adverse event data and identify signals.

• Presented aggregate findings to regulatory bodies, ensuring adherence to guidelines.

Regulatory affairs involves ensuring compliance with laws and regulations in various industries.

• Regulatory affairs professionals work to ensure that products and services meet legal and regulatory requirements.

• They may be involved in obtaining approvals for new products or maintaining compliance for existing ones.

• Examples of industries that require regulatory affairs expertise include pharmaceuticals, medical devices, food and beverages, and cosmetics.

• Regulatory affairs profe...read more