Clinical Safety Scientist

hace 2 meses


Bogotá, Colombia MSD A tiempo completo

Job Description

Individual Case Medical Review (ICMR)

 

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

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

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.

Preferred: 

  • Experience in patient care setting, drug safety and pharmaceutical drug development

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R282592


  • Drug Safety Scientist

    hace 2 días


    Bogotá, Bogotá D.E., Colombia Organon A tiempo completo

    Job DescriptionThe PositionSupports the Global Pharmacovigilance and Safety Science (GPSS) team in safety surveillance and risk management of established brand products and key new asset products.Authoring regulatory documents and aggregate safety reports with cross-functional collaboration.Assists with safety surveillance review activities of adverse...


  • Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

    Job DescriptionThe Department of Medical Writing in the Global Clinical Trial Operations supports the clinical development portfolio by preparing various regulated documentation. Our team in Clinical Research and Pharmacovigilance is dedicated to advancing global healthcare through research and innovation, ensuring the safety and efficacy of our products for...

  • Lead CRA.

    hace 4 semanas


    Bogotá, Colombia PSI A tiempo completo

    Job Description In this role, you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level. Only CVs in English will be considered.  You will: Facilitate regional projects...


  • Bogotá, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • LATAM Technical Manager

    hace 3 semanas


    Bogotá, Colombia Vantage Specialty Chemicals A tiempo completo

    Vantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW’S SOLUTIONS TODAY.As a company on the move, you’ll be working as part of a collaborative team and...