外资制药岗位职责

药物警戒经理-外资制药 Responsible for the line-management of individuals within a team as well as a project team.

Manage direct reports to ensure staff training records are up to date.

Responsible for managing performance reviews and issues of direct reports.

May manage individuals across multiple teams and will take on responsibility for cross department projects.

Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).

May lead or assist with the management of PVDSS concerning project allocation and resourcing.

General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:

Entry of safety data onto adverse event tracking systems

Review of adverse events for completeness, accuracy and appropriateness for expedited reporting

Write patient narratives

Code adverse events accurately using MedDRA

Determine expectedness/listedness against appropriate label

Identifies clinically significant information missing from initial reports and ensures its collection

Ensure cases receive appropriate medical review

Prepare follow-up correspondence consulting with the medical staff accordingly

Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines

Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines

General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to:

Review and update adverse event databases and tracking systems

Review of adverse events for completeness, accuracy and appropriateness for ESR

Review of patient narratives

Review the coding of adverse events

Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines

Complete triage, distribution checklist and quality review of all ESR for assigned projects.

Execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.

Maintain awareness of Covance’s safety database conventions and system functionality.

Maintain awareness of other client safety database conventions and functionality.

May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reportingResponsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.

Provide oversight and management of EudraVigilance activities for assigned projects.

Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.

Contribute to the generation and review of Time and Cost Estimates for PVDSS business.

Work closely with the clinical operations and project management groups to ensure all drug Responsible for the line-management of individuals within a team as well as a project team.

Manage direct reports to ensure staff training records are up to date.

Responsible for managing performance reviews and issues of direct reports.

May manage individuals across multiple teams and will take on responsibility for cross department projects.

Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).

May lead or assist with the management of PVDSS concerning project allocation and resourcing.

General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:

Entry of safety data onto adverse event tracking systems

Review of adverse events for completeness, accuracy and appropriateness for expedited reporting

Write patient narratives

Code adverse events accurately using MedDRA

Determine expectedness/listedness against appropriate label

Identifies clinically significant information missing from initial reports and ensures its collection

Ensure cases receive appropriate medical review

Prepare follow-up correspondence consulting with the medical staff accordingly

Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines

Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines

General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to:

Review and update adverse event databases and tracking systems

Review of adverse events for completeness, accuracy and appropriateness for ESR

Review of patient narratives

Review the coding of adverse events

Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines

Complete triage, distribution checklist and quality review of all ESR for assigned projects.

Execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.

Maintain awareness of Covance’s safety database conventions and system functionality.

Maintain awareness of other client safety database conventions and functionality.

May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reportingResponsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.

Provide oversight and management of EudraVigilance activities for assigned projects.

Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.

Contribute to the generation and review of Time and Cost Estimates for PVDSS business.

Work closely with the clinical operations and project management groups to ensure all drug