Scientist, Drug Safety

Job Description

The 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.  Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration 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.

·       May collaborate with cross-functional colleagues as needed.

·       Complete protocol specific activities as required

·       Actively participate and ensure effective communication with protocol lead and other team

members supporting their protocols

·       Appropriately escalate protocol or individual event issues with other stakeholders including

CRAs/CRMs

Required Skills:

Adaptability, Adaptability, Adverse Event Report, CiviCRM, Clinical Development, Clinical Medicine, Clinical Physiology, Clinical Reporting, Clinical Risk Management, Clinical Sciences, Clinical Trial Management, Clinical Trials Monitoring, Cross-Functional Collaboration, Data Integrity, Data Management, Detail-Oriented, Drug Safety Surveillance, Good Clinical Practice (GCP), Medical Device Management, Pharmacokinetics, Product Development, Protocol Development, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/28/2026

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