Icmr - Clinical Safety Scientist (Css)

hace 6 días

Bogotá Cundinamarca, Colombia MSD A tiempo completo

**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

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
09/18/2024

**Job Posting End Date**:09/18/2024

**Requisition ID**:R314037

  • Sr. Scientist, Drug Safety

    hace 4 días

    Bogotá, Colombia MSD A tiempo completo

    The Sr. Scientist Drug Safety will perform in line medical safety review of individual case safety reports (ICSRs) reports and other AE reports of interest: 1. As required per SOP and in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead performs adverse experience reports review from specified sources in the safety database for...

  • Medical Safety Reviewer

    hace 4 días

    Bogotá, Colombia MSD A tiempo completo

    The Medical Safety Review (MSR) Physician will: 1. Provide in-line medical review of individual case safety reports, clinical trials and other sources, as required, and will include the following actions: Determine or confirm the need for expedited reporting to regulatory agencies, ensure the quality coherence, and accuracy of the case narrative, performs a...

  • Sr. Scientist, Drug Safety

    hace 2 semanas

    Bogotá, Colombia MSD A tiempo completo

    Job description Clinical Safety and Risk Management Associate: - Performs safety surveillance review of adverse experience reports as per SOP with the CSRM team in order to assist with the monitoring and description of the safety profile of assigned products and to identify and respond to safety issues. - Prepares responses to safety inquiries from health...

  • Sr Medical Scientist

    hace 6 días

    Bogotá, Colombia Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** Sr Medical Scientist Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

  • Drug Safety Associate

    hace 2 semanas

    Bogotá, Cundinamarca, Colombia ICON A tiempo completo

    As a Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and...

  • Senior Statistical Programmer

    hace 3 días

    Bogotá, Colombia ICON A tiempo completo

    A leading healthcare intelligence organization is seeking a Senior Statistical Programmer/Data Scientist. You will analyze clinical trial data and ensure high-quality results through statistical programs. Key qualifications include a degree in Statistics or a related field and proficiency in SAS, R, or Python. The role offers competitive salary and benefits,...

  • Director of Clinical Operations

    hace 2 semanas

    Bogotá, Cundinamarca, Colombia Specialty Care Clinics A tiempo completo

    **Key Responsibilities**: - Oversee daily clinical operations, ensuring high-quality patient care and efficient workflows across departments. - Collaborate with medical staff and administrative teams to improve operational processes and patient outcomes. - Develop and implement policies and protocols that align with both **local regulations** and **US...

  • Clinical Pharmacy Analyst

    hace 6 días

    Bogotá, Colombia Oak Lawn Pharmacy A tiempo completo

    **Clinical Pharmacy Analyst** **Location**: Bogotá, Colombia **Company**: GLOBAL AI INTERLINK S.A.S. **Schedule**: Monday to Friday, 9:00 a.m. - 5:30 p.m. **Employment Type**: Permanent / Full-time **Salary**: Starting at **COP $2,500,000/month** **Work Mode**: On-site **Ready to take your first big step in clinical pharmacy? Let’s do it together!** At...

  • Senior Director, Real-World Evidence Operations

    hace 7 días

    Bogotá, Colombia Syneos Health, Inc. A tiempo completo

    A leading biopharmaceutical solutions organization is seeking a Sr Medical Scientist based in Bogotá, Colombia. The role involves developing medical plans, conducting data reviews, and ensuring the scientific integrity of clinical trials. The ideal candidate has a PhD and experience in a Clinical Research Organization. This position offers a chance to...

  • Head of Ehw Americas Clinical Ops

    hace 16 horas

    Bogotá, Colombia Johnson & Johnson A tiempo completo

    **Job Function**: Human Resources **Job Sub Function**: HR Business Partners **Job Category**: People Leader **All Job Posting Locations**: Bogotá Distrito Capital, Colombia **We are searching for the best talent for Head of EHW Americas Clinical Ops in Bogotá, Colombia** Our Employee Health and Well-Being (EHW) organization is dedicated to the total...