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  • ID
  • Job type
  • Salary
    $105 - $115 per hour
  • Source
    Real Staffing
  • Date
  • Deadline

Safety Physician

New Jersey, Princeton, 08542 Princeton USA

Vacancy expired!

Safety Physician

Duration: 6-month contract

Compensation: $105-115 per hour

Location: Princeton, New Jersey

Openings: 3

  • Regularly review results of all available data from external and internal sources, spontaneous adverse event reports, and cumulative data from non-spontaneous (solicited) sources, provide medical clinical expertise for causality assessments and reporting of data and assessment results to internal (e.g., SMT) and external stakeholders (e.g., Health Authorities)
  • Provide documented medical safety input for product quality Communicate any safety signals /issues that have a potential quality component arising during evaluation of medical safety issues to Q&C or those without a quality component but may require market action to the QRB.
  • Provide medical safety input and oversight of preparation of responses to safety- related queries from Health Authorities; make decision if initiation of a prompt communication to patients, health care professionals (e.g., Dear HCP letters), and HA is required and provide medical input to such communications
  • Give strategic guidelines for how Consumer safety should support Medical Affairs; review framework for appropriate representation during safety-related regulatory inspections and internal quality assurance / corporate compliance audits; proactively provide strategic leadership role in organizational strategy, goals, and objectives for
  • Ensure strategic insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols; oversee approval of safety-related content for press releases and other public and professional
  • Responsible for applying industry-leading operational strategy and criteria for appropriate escalation of safety-related issues and remedying Provides final decision-making for rollout and implementation of new safety initiatives.
  • Initiate escalation of safety signals/issues, including those requiring a field action, to the Consumer MSC and senior management as Coordinate with cross-functional team to prepare and present new product development programs to Consumer Medical Safety Council.
  • Provide safety expertise and decisions to Labeling Working Groups (LWGs), including review and endorsement of new safety information in new/revised CCDS, in accordance with applicable
  • Provide input into aggregate safety reviews and advise on the appropriate strategy for Benefit /Risk Evaluation, and participate in appropriate Risk Management activities (e.g., Product Risk Management).

Experience/Skills Required

  • Minimum of 5 years of medical/clinical experience
  • Minimum of 5 years of experience in pharmacovigilance and/or drug/device experience in medical safety Consumer sector or drug safety or development in Pharma and Medical Devices sector and safety inspections and understanding of global safety regulations preferred.
  • Education: Physician (MD) with postgraduate training.
  • Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
  • Experience in risk evaluation and mitigation
  • Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports; experience in preparing RMPs, PSURs

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit www.realstaffing.com

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