Clinical Safety Scientist
Merck Sharp & Dohme Corp.
Bogotá, CO
hace 5 días

Clinical Safety Scientist Job

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Enter your email to apply Requisition ID : DRU000880

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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.

Under the direction of the manager, the CSS will be responsible for intake, initial review, query management and creation of case reports for all reportable safety events according to standard operating procedures.

In addition, the CSS will collaborate with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.

The CSS may participate in cross functional or internal initiatives and / or process improvement projects.

  • Intake of reportable safety event information from clinical trial investigator sites (Serious Adverse Experiences (SAE), Events of Clinical Interest (ECI), pregnancy and lactation exposure events)
  • Review, manage and create case reports for all reportable events
  • Ensure that all information required for a complete and accurate case is present.
  • Triage safety queries from the clinical team and medical safety review.
  • Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness
  • Prioritize daily work to ensure all events are submitted to case processing for entry into the safety database within the established timeframes.
  • Participate as an extended member of the Medical Monitoring Team.
  • Reconcile critical data points between clinical and safety database.
  • Collaborate closely with cross functional colleagues in clinical development, clinical operations, medical safety review and case processing within HQ for AE / drug safety issues.
  • May collaborate with external colleagues, business partners or vendors
  • May lead a team of junior colleagues or contract employees in support of a large complex trial.
  • May serve as an expert resource for less experienced colleagues.
  • May provide training / coaching for new employees
  • May serve as a subject matter expert (SME) for a process, program, case type or therapeutic area.
  • May participate in cross-functional or internal initiatives and / or process improvement projects.
  • Qualifications

    Medical Doctor degree with 1 year of clinical work experience in a patient care setting

    or 2 years relevant pharmaceutical, drug development, and / or drug safety experience.

    Strong understanding of scientific and medical concepts

    Basic understanding of drug development

    Knowledge of GCP and ICH regulations

    Experience working as part of a cross-functional team setting

    Effective problem solving skills

    Must have excellent project management, and time management / organizational skills

    Strong communication skills with advanced oral and written English skills.

    Advanced computer / database skills.

    Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

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