Manager of Drug Safety Center

Company: PRA Health Sciences
Location: Charlottesville
Posted on: October 14, 2020

Job Description:

Who are we?We Are PRA.We are 17,000+ employees strong, operating in more than 90 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 is unquestioned. You are a specialist in pharmacovigilance!As you've evolved in your career, you've taken on greater responsibilities, to include project and team leadership. You have served as the primary point of contact on safety projects, providing technical and process oversight, as well as writing Safety Management Plans and contributing to aggregate reporting, signal detection and risk management activities. As a team lead or experienced manager, you've coached and mentored less experienced team members and managed project resourcing.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 leading a team of experts as zealous about their work as you are. A place where you can really make a difference.You are a Manager of Drug Safety!What will you be doing? As a Manager of the Drug Safety Center (DSC), you'll be managing personnel within the DSC, such as Drug Safety Associates, Safety Data Coordinators and Safety Assistants, to provide services for Serious Adverse Events/Adverse Reactions management, periodic safety reports, literature surveillance and coding. Key responsibilities include:* Managing resources and resource projections to meet client expectations and contractual obligations* Monitoring projects to assure PRA profitability and project goals are met* Providing leadership in the delivery of services to clients* Supporting development of SOPs and investigation of process-related issues, as well as consulting on safety processes and regulatory compliance* Developing PRA employees to ensure high quality work performance and retention of high quality employeesWhat do you need to have?* Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required.* Substantial pharmaceutical or contract research organization experience including project leadership and management of technical staff required.* Minimum of 3-5 year's experience in pharmacovigilance and / or related services required.* Experience preparing, implementing, and managing group operational plans, budgets and profitability.* Knowledge of regulatory submissions requirements for human drugs, biologics and/or devices required.* Skills with industry standard safety or clinical data bases.* Read, write and speak fluent English; fluent in host country language required.* Good written, oral communication and presentation skills.* 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.

Keywords: PRA Health Sciences, Charlottesville , Manager of Drug Safety Center, Executive , Charlottesville, Virginia