Job for Drug Safety Manager at Covance
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Mgr Drug Safety
• Line manage PV&DSS staff including performance reviews, human resource issues, and assist Senior PV&DSS Management in assigning resources to projects.
• Manage the overall PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports) for specified projects.
• Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• 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 PV&DSS 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
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
• 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 PV&DSS business.
• Work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.
• Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
• Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.
• Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards.
• Assist in the co-ordination of endpoint committees.
• Participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as lead contact for projects including global projects ensuring communication and processes are harmonized.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Consistently contributes to solving technical and/or operational problems of program/project members.
• Consistently proposes and executes innovative solutions which influence program/project direction.
• Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Effectively draft/modify and deliver safety presentations:
• Serious Adverse Event reporting at investigator meetings.
• Client capabilities meetings, as appropriate
• “Department Overview” to internal clients
• Attend client meetings and liaise with clients where appropriate.
• Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• Participate in Covance project teams and provide training about adverse event reporting to non-PV&DSS personnel.
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