• Safety Scientist 1 (Mgr) - Patient Safety and Pharmacovigiliance

    Job Locations - | US-Remote | US-IL-Chicago | US-MA-Boston
    Posted Date 2 weeks ago(2 weeks ago)
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?


    Because we’re hoping you’re here for the latter.


    Who are we?

    We Are PRA.


    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.


    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Safety Scientist, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


    Still here? Good. Because if this is you, we’d really like to meet you.


    What will you be doing?


    As a Safety Scientist, you will provide internal and external project teams with expert knowledge of global aggregate safety reporting requirements and procedures, PRA standards, procedures and interpretation of those same global requirements, and an aggregate report project management service that ensures compliance and consistency of aggregate reports across the portfolio for our clients.


    • Provides project team with expert knowledge on aggregate report requirements for medicinal products and devices and risk management
    • Assists project team in client meetings, when aggregate safety reporting questions which require expert knowledge beyond the expertise of Drug Safety Associates and/or Safety Data Coordinators are discussed
    • Coordinates and facilitates specialized Safety and Risk Management services, for the production of aggregate safety reports, including PBRERs, PADERs, ACOs, dRMP/RMP, SUSAR Line Listings, Enhanced PV Reporting and other country specific aggregate reports
    • Provides project management and coordination of production for Aggregate Safety Reports
    • Ensures final aggregate report deliverables are consistent across the portfolio and conform to quality standards and global requirements
    • Liaises with license partners on behalf of our clients in the request or provision of; aggregate safety reports or data for aggregate safety reports
    • Works with global stakeholders to maintain streamlined and compliant global aggregate report schedules
    • Participates in initiatives for the implementation and integration of new or enhanced:
      • Safety & Risk Management processes and best practices
      • Safety & Risk Management systems, databases and tools
    • Identification and notification of gaps/weaknesses in aggregate report templates and guidance documents together with proposed solutions for implementation. Includes monitoring of standard MedDRA terms for routine searches.



    What do you need to have?

    Education: Bachelor’s degree OR its international equivalent required. Degree in life science and/or healthcare-related field, strongly preferred.


    • Substantial pharmacovigilance (PV) or post-marketing safety surveillance experience required with a minimum of 5 years of experience in pharmacovigilance or medical coding or in a similar field.
    • Writing safety management reports OR PV quality oversight of aggregate safety reports with an in-depth knowledge of PV, in particular US aggregate safety report regulation
    • Read, write, and speak fluent English; fluent in host country language required.
    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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