PRAHS

Returning Candidate?

2017-43607

2017-43607

Title 
Safety Scientist 1
Job Locations 
-
US-VA-Charlottesville
US-NC-Raleigh
US-PA-Blue Bell
US-IL-Chicago
US-MA-Boston
Canada-Remote
US-Remote
Posted Date 
10/30/2017

More information about this job

Overview

“Grandma’s starting chemotherapy tomorrow.  Is it safe?”

 We’re hoping you want to find out.

 

 

Who are we?

We Are PRA.

 

We are 12,000+ employees strong, operating in more than 80 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 help get life-saving drugs into the hands of those who need them most.

 

Who are you?

You’ve dedicated your career in support of the development of new and innovative therapies, helping to make safer effective treatments available to the public. Your career trained you to be incredibly thorough and you can track down and document to detail all the relevant facts about an untoward drug effect like a detective. The accuracy and reliability of your work and your analytical skills are unquestioned. You are in pharmacovigilance expert!

 

As you’ve evolved in your career, you’ve taken on greater responsibilities, including project and team leadership. You have served as the facilitator, coordinator and primary point of contact on safety projects, providing technical and process oversight, as well as writing Safety Management Plans and overseeing aggregate reporting, signal detection and risk management activities. As a team lead, you’ve coached and mentored less experienced team members and served as the safety subject matter expert with clients.

 

Confident in your understanding of the regulatory environment and pharmacovigilance, you want to find a work/life balance that lets you pursue your career passion and still be, well, you. Most of all, you want to do it in a place where you’re part of a team of experts as zealous about their work as you are…a place where you can use your in-depth safety surveillance knowledge to really make a difference.

 

You are a Safety Scientist!

 

 

 

Responsibilities

What will you be doing?

As a Safety Scientist, you will provide internal and external project teams with expert knowledge on safety surveillance for medicinal products, risk management, and medical coding questions. Also, you will support or initiate process and system development or improvement activities.

 

Key responsibilities include:

  • Facilitating specialized Safety & Risk Management services, such as generating aggregate safety reports, dRMP/RMP, and Literature Search and Review Algorithms, and their associated plans
  • Performing quality control activities like review of draft planning documents (i.e., Safety & Medical Management Plans, SAE/AE Reconciliation Plans) and review of Coding Consistency listings
  • Developing and delivering training courses on Safety & Risk Management related topics to PRA employees within and outside Safety & Risk Management, as well as to external parties (i.e., investigators, clients)
  • Coordinating benefit risk evaluation activities, such as drafting required plans and documenting benefit risk evaluation activities
  • Coordinating and leading planning and conduct of adjudication services
  • Coordinating and leading all aspects of literature search and review for routing pharmacovigilance or aggregate product safety analysis
  • Displaying an industry presence by writing articles for industry publications and giving presentations at industry conferences

Qualifications

What do you need to have?

  • Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required
  • Substantial clinical research or post-marketing safety surveillance experience required, with a minimum of 5-7 years experience in pharmacovigilance
  • Experience in leading professional staff in a safety surveillance, risk management and medical coding environment required with proven ability to oversee, mentor and effectively manage co-workers
  • Proven history of successful involvement driving a global initiative
  • Skills with industry standard safety or clinical data bases
  • Good written, oral communication and presentation skills
  • 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.

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