Clinical Safety Scientist

Merck

Bogotá (Colpatria), Cundinamarca, COL

hace 1 día

Job Description

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

Current Contingent Workers apply

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 : No relocation

VISA Sponsorship :

Travel Requirements :

Flexible Work Arrangements :

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :

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