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无工作经验 -
招1人 -
11-09 发布
- 五险一金
- 专业培训
职位描述
职位描述： *Responsibilities/Duties? Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.? Monitor and manage the workflow for assigned projects to ensure all deadlines are met and 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 making decisions regarding adverse event reporting within the guidelines of each assigned project.? Work closely with the clinical operations and project management groups to ensure all PV&DSS activities are performed according to the regulatory and contractual requirements.? Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.? Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects.? Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.? Complete triage, distribution checklist and quality review of all ESRs for assigned projects.? Provide oversight and management of EudraVigilance activities for assigned projects.? Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions and system functionality? Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.? Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.? Provide oversight and/or preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.? Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.? Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.? Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.? Attend client meetings and liaise with clients where appropriate.? Consistently contributes to solving technical and/or operational problems of program/project members.? Consistently proposes and executes innovative solutions which influence program/project direction.? Provide PV&DSS project training for assigned projects for PV&DSS, Clinical Operations/Project Management, Client and Investigators as required.? Prepare and participate in audits, either by the client or a regulatory agency.? Maintenance of files regarding adverse event reporting requirements in all countries.? Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients.? Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.? Manage the co-ordination of endpoint committees as needed.? Work with Data Management or client on reconciliation of safety databases, if appropriate.? Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.? Prepare and deliver safety presentations? Maintains a comprehensive understanding of PV&DSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.? Possess knowledge of other CDS procedural documents, e.g., SOPs, WIs, etc. impacting safety? Contribute to the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate*Education/QualificationsRequired:? Non-degree + 6-7 yrs safety experience*? Associates Degree + 5-6 yrs safety experience*? Associate degree RN + 5-6 yrs safety experience*? BS/BA + 4-5 yrs safety experience**? MS/MA + 2-3 yr relevant experience**? PharmD + 1-2 yrs relevant experience**Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.*Experience*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.EudraVigilance Certification preferred 职能类别： 生物工程/生物制药
联系方式
酒仙桥路10号恒通商务园20号楼
公司信息
Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!
