Job Description

The Senior Scientist, Clinical Safety Scientist (CSS) supports safety reporting for clinical trials across multiple therapeutic areas and investigational product development programs, from early- through late-stage development. This includes in-house trials and may include support for outsourced trials from integrations. The CSS collaborates with cross-functional colleagues in clinical development, clinical operations, case processing, and medical safety review.

Key Responsibilities

- Intake, review and management of individual reportable safety events from clinical trial investigator sites.
- Ensure that all information required for a clinically complete and accurate case is present.
- Develop clinically focused safety queries for trial investigator sites to support accurate and complete case reports.
- 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.
- Maintain Protocol Specific Training (PST) requirements for assigned trials, including new amendments, to ensure protocol knowledge and understanding of their impact on safety reporting.
- Actively participate and ensure effective communication with other team members supporting their protocols.
- Appropriately escalated protocol or individual event issues with other stakeholders including CRAs/CRMs/CS/CD.
- May lead one or more protocols (as a protocol lead).
- Triage safety queries from the clinical team and medical safety review team (ICMR-MSR) as applicable.
- As a protocol lead participate as a core member of the Medical Monitoring Team.




- As a protocol lead participate and collaborate with the Clinical Trial Team.
- As a protocol lead reconcile critical data points between clinical and safety database as required.
- Collaborate closely with cross functional colleagues.
- Collaborate with external colleagues and business partners.
- May serve as an expert resource for less experienced colleagues.
- May provide training /oversight 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.

Education Requirement

Bachelor's degree in Medicine Advanced English proficiency (C1 level). Proof of proficiency may be required.

Work Experience

Minimum of 2 years of relevant professional experience in clinical practice and/or the pharmaceutical industry, including drug safety, clinical trials, drug development, with at least 1 year of clinical experience in a patient care setting.

Qualifications & Skills

- Strong understanding of scientific and medical concepts.
- Basic understanding of drug development.
- Knowledge of GCP and ICH regulations.
- Ability to work as part of a cross-functional team.




- Effective decision making and independent problem-solving skills.
- Time management and organizational skills.
- Strong communication skills with advanced oral and written English skills.
- Advanced computer, database skills.
- Able to work under pressure, strong sense of responsibility and accountability.

Required Skills

- Adaptability
- Adverse Event Report
- Biopharmaceutical Industry
- Clinical Development
- Clinical Experience
- Clinical Medicine
- Clinical Physiology
- Clinical Sciences
- Clinical Trials
- Cross-Functional Collaboration
- Data Analysis
- Data Integrity
- Decision Making
- Drug Development
- Drug Safety Surveillance
- Good Clinical Practice (GCP)
- Medical Writing
- Pharmacovigilance
- Process Improvement Projects
- Process Improvements
- Regulatory Compliance
- Risk Management
- Safety Reporting
- Strategic Thinking

Location: Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

Contract type: Project Temps (Fixed Term).

Job Posting End Date: 08/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

Our company is a general health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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