北京招聘

职位描述：
*Responsibilities/Duties
Manager of DSS
Job summary:
? Line manager 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 trial and /or post marketing setting (i.e. unsolicited reports) for specified projects.
? Manage the process expeditable adverse events to the required standard and submit them to the client and regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to client 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.
Essential job duties:
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 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.
General oversight for the management and processing of expeditable safety reports (ESRs).
Complete triage, distribution checklist and quality review of all ESR for assigned projects
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 team in the reconciliation of SAEs across safety and trials databases.
Contributes to the development and/or review of clinical trial protocol, case report forms and adverse event reporting forms
Effectively draft / modify and deliver safety presentations
Ensure compliant safety reporting in accordance with international reporting regulations, SOP and safety processing guideline set forth by departmental management team.
Participate in Covance project teams and provide training about adverse event reporting to non-PV&DSS personnel.
Train new employees overall all pharmacovigilance and regulatory reporting.
Any other duties as assigned by management.
*Education/Qualifications
Associate degree RN + 5-6 yrs safety experience; OR BS/BA + 4-5 yrs safety experience; OR MS/MA + 3-4 yrs relevant exprience (2-3 yrs safety experience); OR PharmD + 2-3 relevant experience (1-2 yrs safety experience)
*Experience
Experience:
At least yrs line management and / or project management experience for drug safety.
Industry experience of which 4 years is relevant to pharmacovigilance/drug safety knowledge
Good verbal, written and presentation skill
Work collaboratively with PV&DSS management’s team
Leadership capabilities
Good communication
Ensure client and global regulatory compliance 举报 分享

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