Director of Pharmacovigilance

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 Director of Pharmacovigilance in Princeton, New Jersey.  The Director of Pharmacovigilance role will have medical oversight of global pharmacovigilance activities for clinical trials and product development, and will also lead the pharmacovigilance team. As they partner with the Pharmacovigilance team and the Clinical Drug Safety Department, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!

RESPONSIBILITIES

  • Monitor compliance of Pharmacovigilance with GVP, GCP, and all applicable regulations
  • Ensure monthly Safety Reporting Compliance metrics of individual, aggregate, and periodic reports are compliant both in terms of quality and timelines for in-house and contracted services
  • Write and monitor compliance for all necessary SOPs 
  • Oversee all PV Vendors
  • Certify all critical and major GVP non-compliance issues are put through the CAPA process
  • Guarantee all PV CAPAs for audit/inspection findings (and the deviations) are closed by the due dates
  • Ensure that all pharmacovigilance staff has a training matrix, comply with it & documented it in the documentation system.
  • Maintain a state of pharmacovigilance inspection preparedness
  • Evaluate and interpret adverse event/serious adverse event reports and other documents used in Safety Pharmacovigilance submissions
  • Establish and maintain policies and procedures for the Clinical Drug Safety Department
  • Provide oversight for the medical review of serious adverse event reports (SAE’s) to ensure accuracy, integrity and completeness of safety information and to ensure consistency of medical coding of safety data
  • Manage the safety product profiles, including signal detection, and responsibility for risk Lead risk management activities, including risk identification, risk evaluation, and development of appropriate risk and safety management plan (SMP) documentation).
  • Assess single case safety reports and aggregate trend analysis 

EXPERIENCE

  • 8-10 years of experience of pharmacovigilance experience in a global environment
  • Knowledge of relevant FDA, EU and ICH guidelines, initiatives, and regulations governing both safety reporting and processing for clinical trial environments
  • Expertise in SAE analysis and SAE coding 

EDUCATION

  • MD Degree required

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.

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