Safety Data Manager

Princeton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Safety Data Manager in Princeton, New Jersey, for a 12-month project.  The Safety Data manager reports to the Directory Safety Data Management within Clinical Safety and Pharmacovigilance and will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Support Argus Safety system by managing user requests throughout their full life-cycle 
  • Lead, define, design, develop and test Argus and E2B configurations to satisfy business user requirements
  • Ensure maintenance of the validated state of the safety system by conducting or overseeing validated tasks performed for all changes 
  • Assist with report and query development by applying knowledge of SQL
  • Support the Global PV user community by meeting defined Service Level Agreements

EXPERIENCE

  • A minimum of 5 years of experience and detailed knowledge of ICH E2B R2 requirements, Argus E2B and gateway configuration
  • Detailed knowledge of Argus Safety Web configuration
  • Demonstrated experience in conducting E2B pilots with Regulatory Agencies and partners

EDUCATION

  • Bachelors of Computer Science, Engineering, Business Administration minimum
  • Masters in technology/systems related field preferred

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176