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Principal Safety Specialist

Company: Precision Medicine Group
Location: Gladstone
Posted on: June 9, 2024

Job Description:

Principal Safety Specialist
at Precision Medicine Group (View all jobs)
Remote, United States

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a Principal Safety Specialist?

Position Summary:

Responsibilities will include but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

Essential functions of the job include but are not limited to:

  • Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems
  • Participate in the assessment and set-up of a safety database to capture SAE data
  • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures
  • QC of documents and safety reports
  • Preparation and/or review of project specific safety reporting plans and medical coding plans
  • Preparation and/or review of safety training materials
  • Develop and manage standard operating procedures and work instructions
  • Serve as subject matter expert for department
  • Provide ongoing training and mentorship for Safety Specialists
  • Participate in audits and audit preparation, kick-off meetings, and investigator meetings
  • Participate in bid defenses for existing and potential clients
  • Assist departmental management with resource management
  • Assist departmental management with oversight
  • Serve as project manager for safety standalone projects
  • Lead departmental initiatives and cross-functional development activities
  • Assist clients and/or other departmental staff with safety-related reviews and other services

    Minimum Required:
    • BA/BS degree
    • 10+ years clinical safety experience
      Other Required:
      • Health care professional
      • Hands on experience with global safety database(s), SAE case processing, and safety reports generation
      • Working knowledge of MedDRA and WHODrug
      • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations
        • Nursing or pharmacy degree
        • Industry experience in CRO or pharmaceutical company

          Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

          Reasonable estimate of the current range

          $106,400 - $159,600 USD

          Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .

          Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. - 2020 Precision Medicine Group, LLC

          If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .

Keywords: Precision Medicine Group, Plainfield , Principal Safety Specialist, Other , Gladstone, New Jersey

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