Clinical Safety Scientist - #2812221

Clinical Safety Scientist 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.

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
Reconcile critical data points between clinical and safety database
Collaborate closely with cross functional colleagues

Required qualifications, skills & experience:
Strong understanding of scientific and medical concepts
Basic understanding of drug development
Experience working as part of a cross-functional team setting
Effective problem-solving skills
Time management/organizational skills
Strong communication skills with advanced oral and written English skills ( >90%)
Advanced computer, database skills
Office tools management (Word, Excel, Power point)

Education Requirement:
M.D with 1 year of clinical work experience in a patient care setting (different from medical internship) or 2 years relevant pharmaceutical, drug development, and/or drug safety experience

Preferred:
Basic knowledge of GCP and ICH regulations
Experience in drug safety
Experience in pharmaceutical drug development

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:
No relocation

VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID: R189107