Job Description
Clinical Safety Scientist
The 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. 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, manage and create 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 the protocol lead and other team members supporting their protocols.
Appropriately escalate protocol or individual event issues with other stakeholders, including CRAs/CRMs or protocol leads.
Qualifications & Skills
Basic understanding of scientific and medical concepts
Basic understanding of drug development
Basic knowledge of GCP and ICH regulations98
Ability to work as part of a cross-functional team
Ability to identify and escalate problems and contribute to issue resolution
Time management and organizational skills
Strong communication skills with advanced oral and written English skills
Advanced computer, database skills
Independent, strong analytical, and problem-solving skills
Able to work under pressure, with a strong sense of responsibility and accountability.
Education Requirement:
M.D. with minimum 1 year of clinical work experience in a patient care setting or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.
Education Requirement:
M.D./D.O. or equivalent degree in Medicine
Work Experience:
Minimum 1 year of Experience in a patient care setting, or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.
*Please submit your CV in English
Required Skills:
Adaptability, Adaptability, Adverse Event Report, Clinical Development, Clinical Medicine, Clinical Reporting, Clinical Trial Management, Clinical Trials Monitoring, Cross-Functional Collaboration, Data Integrity, Data Management, Detail-Oriented, Drug Development, Drug Safety Surveillance, Good Clinical Practice (GCP), Medical Device Management, Pharmaceutical Development, Pressure Management, Product Development, Protocol Development, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation, Regulatory Reporting, Training and Development {+ 1 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
Project Temps (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/30/2026*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.