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发帖数: 18 | 1 全球500强的药物研发公司，紧急招聘药物警戒方向上的PV Lead, senior manager.
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Position Purpose
· Develop and maintain knowledge of applicable SOPs, Safety Job
Aids and the Argus User Reference Guide..
· Develop and maintain current knowledge of assigned products
within a therapeutic area.
· Maintain working knowledge of applicable corporate and global
regulations/guidelines.
· Develop an understanding of the importance of ICSR processing to
aggregate report quality and timeliness.
· Contribute to ‘Right First Time’ initiatives.
Primary Responsibilities
· Manage the case-flow process across a multi-functional
therapeutic team to ensure timely and accurate processing of adverse event
cases to meet corporate and regulatory reporting requirements.
· Provide oversight and guidance to Safety Surveillance Associates
and Safety Surveillance Specialists on review and processing of adverse
event reports.
· Manage the team’s case processing to ensure complete and timely
submission to the PSSR aggregate reports group.
· In cooperation with the Therapeutic Area Head and Business
Planning Leads, manage available resources to ensure effective processing of
PSSR caseload, processing cases when necessary.
· Take responsibility for implementing the corrective actions
resulting from timeliness or quality issues associated with case processing.
· In the absence of the Therapeutic Area Head, act as point of
contact for the therapeutic area team.
Technical Skill Requirements
· Strong interpersonal skills, with a demonstrated ability to
manage people and foster teamwork.
· Demonstrable understanding of safety report processing and
assessment of safety at the Senior Safety Surveillance Associate level;
ability to process cases an advantage.
· Ability to meet personal objectives while meeting departmental
standards of performance.
· Demonstrable skills in project, time and change management,
organizational and facilitation skills.
· Good understanding of medical terminology and familiarity with
principles of clinical assessment of safety reports in the context of an
international pharmaceutical industry.
· Knowledge of global regulations governing safety reporting.
· Demonstrated computer literacy, particularly in the use and
management of relational databases.
· Demonstrable organizational and time management skills, in order
to meet strict regulatory compliance goals.
· Good oral and written communication skills, with fluency in
spoken and written English; knowledge of additional language(s) an advantage.
Qualifications (i.e., preferred education, experience, attributes)
· Bachelor degree in a science-related field, pharmacy or nursing
or equivalent, advanced degree an advantage.
· Minimum of three years research, clinical or equivalent
experience in the pharmaceutical industry; managerial experience in hospital
or pharmacy, and familiarity with clinical assessment is highly desirable. |
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