Position
(short title)：
Safety Data Specialist, Global Pharmacovigilance Case Management (GPVCM)
(SDS GPVCM)

Organization Details：
Global Clinical Trial Operations (GCTO)- Global Data Management & Standards (GDMS)

Brief Description of Position：
The Safety Data Specialist (SDS) is responsible for processing adverse events (AE) information in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SDS should understand the importance of high quality and compliant AE case management. The SDS should also have a clear perception of case management processes, adhere to corporate policies and follow the company’s Ways of Working, including leadership behaviors.

Responsibilities and Primary Activities (may include but are not limited to):

Through daily case prioritization activities, ensures completion of reports within the established internal, business partner and regulatory agency timelines.
Ensures quality and consistency with guidelines.
Performs case translation and/or submission in compliance with requirements of worldwide regulatory agencies.
Indexes AE documents pushed from Central Receiving Mailboxes to the Imaging system with required attributes.
Clarifies discrepancies in the incoming information to achieve unequivocal text in a standardized form.
Effectively communicates with internal and external stakeholders on any inquiry or request.
Exchanges communication with Business Partners (BPs) following agreements, to ensure compliance with internal, BP and worldwide regulatory agency reporting requirements.
Successfully completes training and independence assessment activities for GPVCM specialists.

Location：
Beijing, Chaoyang District, Wangjing Park.

Qualifications, Skills & Experience：
Education and other Qualifications:

Bachelor’s degree in Health Care or role related disciplines
Master’s degree desirable
Advanced writing/reading and intermediate speaking/listening English language skills
Basic IT skills (Outlook, Excel, browsing tools).


Levels required for Core Competences (Classifications of the levels from the lowest to the highest: Learning, Applying, Advanced and Expert)
Professional Competencies
oWorking Across Boundaries (Learning).
oStrategic Thinking (Learning).
oProject Management (Learning).
oProductive Communication (Learning).
oProblem Solving (Learning).
Core Functional Competencies
oData Analysis, Interpretation & Communication (Learning).
oCompetitive Decision Making & Execution (Learning).
oCollaboration & Partnering (Learning).
oBusiness & Operations Management (Learning).
oRegulatory & Compliance Management (Learning).
Disease Area Knowledge (Sub Competencies) (Learning).

薪资面议。

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