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 SSDS 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.
Levels required for Core Competencies:
- Productive Communication: Demonstrate an open and respectful communication style that actively acknowledges others 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.
- Disease Area Knowledge (Sub Competencies): Have knowledge to expand the scope of Case Processing within or across therapeutic area(s)
#R359609
Required Skills:
Case Processing, Clinical Data Management, Clinical Risk Management, Clinical Testing, Data Analysis, Data Processing, Pharmacovigilance, Standard Operating Procedure (SOP)
Preferred Skills:
Korean Language, Management Reporting, Regulatory Compliance
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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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
12/31/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R359609
