This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Project Manager Drug Safety (Any City in China)

Laboratory Corporation of America Holdings (Covance)

Shanghai, China

<h2>Job Overview:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">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. This includes, but is not limited to:</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">entry of safety data onto adverse event database(s) and tracking systems</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review of adverse events for completeness, accuracy and appropriateness for expedited reporting</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">write patient narratives</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">code adverse events accurately using MedDRA</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">determine expectedness/listedness against appropriate label</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">identifies clinically significant information missing from initial reports and ensures its collection</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">ensure case receives appropriate medical review</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">prepare follow-up correspondence consulting with the medical staff accordingly </span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">provide independent QC of AE reports for other members of the group</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide oversight of the management and processing of expedited safety reports (ESRs) for assigned projects. This includes, but is not limited to:</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review and update adverse event databases and tracking systems</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review of adverse events for completeness, accuracy and appropriateness for expedited reporting</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review of patient narratives</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review the coding of adverse events </span></li><li style="margin-left: 36.0pt;"><span style="font-size: 11.0pt;">review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Complete triage, distribution checklist and quality review of all ESRs for assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide oversight and management of EudraVigilance activities for assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions and system functionality</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Attend client meetings and liaise with clients where appropriate.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Consistently contributes to solving technical and/or operational problems of program/project members.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Consistently proposes and executes innovative solutions which influence program/project direction. </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide PV&DSS project training for assigned projects for PV&DSS, Clinical Operations/Project Management, Client and Investigators as required. </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Prepare and participate in audits, either by the client or a regulatory agency.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Maintenance of files regarding adverse event reporting requirements in all countries.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Manage the co-ordination of endpoint committees as needed.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Work with Data Management or client on reconciliation of safety databases, if appropriate.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Prepare and deliver safety presentations:</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Serious Adverse Event reporting at investigator meetings.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Client capabilities meetings, as appropriate</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">“Department Overview” to internal clients</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Maintains a comprehensive understanding of PV&DSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Possess knowledge of other CDS procedural documents, e.g., SOPs, WIs, etc. impacting safety</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Contribute to the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Provide support and training in all aspects of case-handling, adverse event reporting and other tasks for team members of assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Acts as a mentor to less experienced colleagues</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Responsible for cascading relevant information from internal and external meetings to PV&DSS management and appropriate colleagues.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">May supervise workloads and individual performance of more junior team members</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Build and maintain good drug safety relationships across functional units.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Demonstrate role specific Competencies on consistent basis</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Demonstrate company Values on consistent basis</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Financial authority as it relates to projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Any other duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">Level of education required (or experience level which may be substituted for level of education).</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">Professional designations/certifications/licenses required</span></p><ul><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">Non-degree + 6-7 yrs safety experience*</span></li><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">Associate degree + 5-6 yrs safety experience*</span></li><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">Associate degree RN + 5-6 yrs safety experience*</span></li><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">BS/BA + 4-5 yrs safety experience*</span></li><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)</span></li><li style="margin-left: 0cm;"><span style="font-size: 11.0pt;">PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)</span></li></ul><p style="margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 11.0pt;">For PharmD, a one year residency of fellowship can be considered relevant experience.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.</span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 11.0pt;">**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.</span></p><h2>Experience:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Compliance with client and global regulatory requirements</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good knowledge of ICH</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good knowledge of medical and drug terminology</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Work collaboratively with PV&DSS Management’s team</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good verbal, written and presentation skills.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good communication.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Leadership capabilities</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Anticipate/identify problems and takes appropriate action to correct.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Knowledge of aggregate reporting</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 11.0pt;">Financially intuitive</span></li></ul>

Job posted: 2021-07-14

3