Pharmaceutical Research Associates, Inc.
(All) | US-NJOverview "Grandma's starting chemotherapy tomorrow. Is it safe?" We're hoping you want to find out. Who are we?
We Are PRA.
We are 16,000+ 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?
As a practicing nurse or pharmacist, you cared for patients in a hospital environment and you witnessed the promise of many new and innovative therapies, but you also observed those instances where adverse reactions betrayed that promise. Now, you're out of the clinic and dedicated to the effort to making 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 is unquestioned.
You are a drug safety professional! 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 really make a difference. Responsibilities What will you be doing?
As an experienced Drug Safety Associate, you'll be providing management of ICSRs (individual case study reports), reconciliation of SAEs, and coding and data retrievals from the safety database, just to highlight some of the big ones. You'll also be supporting the generation of aggregated safety reports and Data Monitoring Committee (DMC) reviews.
Additionally, you'll be writing concise and accurate narratives and performing coding of diseases and medications. You'll also be participating in quality controls, conducting literature surveillance, developing Safety Management Plans (SMP), and supporting signal detection and risk management activities.
Furthermore, you'll be interacting with client/sponsor organizations on projects you lead via project team meetings. On the projects you lead, you'll provide coaching and mentoring to less experienced DSAs.Qualifications What do you need to have?
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
- Undergraduate degree OR its international equivalent OR equivalent combination of education & experience to successfully perform the key responsibilities of the job
- 2+ years of experience processing ICSRs AND/OR 2+ years of experience as a Clinical Data Coordinator, with at least one year experience as a Lead Clinical Data Coordinator
- Knowledge in pre- and post-marketing Pharmacovigilance, preferred
- Basic knowledge of regulatory environment governing safety and risk management activities, preferred
- Previous experience using computerized information systems and standard application software (Windows, MS Office)
- Good written and oral communication skills
- Must read, write and speak fluent English. Multiple language abilities desirable