Job Description

The Senior Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. The CSS will collaborate with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.     

 

Key Responsibilities:

• Intake of reportable safety event information from clinical trial investigator sites.

• Review and manage individual case safety reports for each event.

• Ensure that all information required for a clinically complete and accurate case is present.

• Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness.

• Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes.

• Complete protocol specific activities as required

• Actively participate and ensure effective communication with other team members supporting their protocols

• Appropriately escalate protocol or individual event issues with other stakeholders including CRAs/CRMs

• Perform protocol lead activities for a trial.

• Triage safety queries from the clinical team and medical safety review team

• Participate as a core member of the Medical Monitoring Team

• Participate as an extended member of the Clinical Trial Team

• Reconcile critical data points between clinical and safety database

• Collaborate closely with cross functional colleagues 

• May collaborate with external colleagues and business partners. 

• May serve as an expert resource for less experienced colleagues.

• May provide training /coaching for new employees. May participate in cross-functional or internal initiatives and/or process improvement projects.

• May provide support to outsourced trials

• May serve as a Business Support team Leader.

Required Skills:

Accountability, Accountability, Adaptability, Adverse Event Report, Clinical Development, Clinical Experience, Clinical Medicine, Clinical Physiology, Clinical Reporting, Clinical Trials, Clinical Trials Monitoring, Data Analysis, Data Integrity, Decision Making, Drug Safety Surveillance, Good Clinical Practice (GCP), Innovation, Machine Learning (ML), Medical Review, Medical Writing, Pharmacovigilance, Process Improvement Projects, Product Development, Regulatory Compliance, Risk Management {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/23/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.