Safety Data Lead I

vor 2 Wochen

Schweiz Merck Sharp & Dohme (MSD) Vollzeit

Job Description

The Safety Data Lead I is responsible for processing adverse experience (AE) reports with high quality and compliance in the global safety system for investigational and/or marketed products, under the direction and supervision of a Global Pharmacovigilance Case Management Manager.

The Safety Data Lead I performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines.

The Safety Data Lead I supports business processes which are important to Global Pharmacovigilance Case Management operations and works closely with other staff within the organization as well as cross-functionally.

Responsibilities and Primary Activities:

  • Perform all core responsibilities of the Safety Data Specialist in addition to expanding the scope of Case Processing activities within or across therapeutic area(s).
  • Independently and consistently meet Key Performance Indicators (KPIs).
  • Serve as a Point of Contact, providing feedback and support to ensure resources (SOPs, guidelines) are updated appropriately to enable quality and compliance of AE reports.
  • Stay abreast of updates to act as resource for questions/clarifications.
  • Assist with the process of root cause analysis and implementation of action plans when appropriate.

Education and other Qualifications:

  • Bachelor's degree or above in Health Care or job-related disciplines.
  • Advanced writing/reading and intermediate speaking/listening Korean & English language skills

Productive Communication:

Demonstrate an open and respectful communication style that actively acknowledges other's ideas in any circumstance and selecting the correct stakeholders.

Business & Operations Management:

Understand and correlate processes and responsibilities within and between pillars and how they are aligned with GPVCM priorities.

Regulatory & Compliance Management:

Apply compliance requirements knowledge to ensure adherence to regulations.

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