Safety Data Specialist(JPV) [China]

 

Job Description

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.

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  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.

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

o Working Across Boundaries (Learning).

o Strategic Thinking (Learning).

o Project Management (Learning).

o Productive Communication (Learning).

o Problem Solving (Learning).

• Core Functional Competencies

o Data Analysis, Interpretation & Communication (Learning).

o Competitive Decision Making & Execution (Learning).

o Collaboration & Partnering (Learning).

o Business & Operations Management (Learning).

o Regulatory & Compliance Management (Learning).

Disease Area Knowledge (Sub Competencies) (Learning).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R242146

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