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 earlyand 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 developmentCurrent Employees apply HERECurrent Contingent Workers apply HERE Search Firm Representatives Please Read CarefullyMerck & 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.