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Clinical Pharmacovigilance Operations Manager - Deerfield, IL or Boston, MA
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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 Clinical PV Operations Manager, 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 Clinical PV Operations Manager, you are responsible for Pharmacovigilance Operations activities for all safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.


  • To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the key functions as determined through an interactive discussion with the employee and in consultation with HR and Legal.
  • Ensures accuracy of triage, assessment and processing of adverse events in the Global Safety Database
  • Ensures compliance with federal regulations and standard operating procedures.
  • Collaborates with medical staff regarding adverse event/safety issues.
  • Collaborates with cross-functional teams to create IND reports and aggregate reports
  • Communicates with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports
  • Determines necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensures that required follow-up for assigned cases has been completed


  • What do you need to have?


    Education:      Degree and healthcare background required (BS/RN/NP/PA/RPH) preferred


    • Strong clinical background required, oncology experience preferred
    • Understanding of local and applicable foreign safety regulations
    • Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
    • Detailed knowledge in the use of drug safety databases (Argus)
    • Practical experience working with MedDRA required
    • Excellent interpersonal, influencing and negotiation skills
    • Strong verbal and written communications and presentation skills
    • Proven problem solving and decision making skills
    • Excellent leadership, management, planning and project management skills
    In addition to the above:
    • 2-3 years experience in processing of ICSR and/or
    • 2-3 years experience as a Clinical Data Coordinator, with at least one year experience as Lead Clinical Data Coordinator
  • Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
  • Knowledge in pre- and post-marketing Pharmacovigilance. Basic knowledge of regulatory environment governing safety and risk management activities.

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

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.


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