Medical Safety Review Physician
Synectics
Lawrenceville, NJ
1d ago

Description

  • Provide high quality medical review of ICSRs including the determination of regulatory reportability of clinical trial cases and certain spontaneous reports.
  • Perform signal detection based on ICSRs and discusses with relevant stakeholders for further action.
  • Provide medical review of individual serious spontaneous reports of adverse events.
  • Provide medical review, perform causality assessment and determine regulatory reportability of clinical trial cases for assigned products and across therapeutic areas.
  • Provide oversight of single case processing vendor re : medical review for products of responsibility.
  • Ensure complete and timely reporting of medical cases to regulatory authorities globally for products of responsibility.
  • Apply company operating philosophy and operate within company policies and procedures and appropriate regulations.
  • Partner with company personnel from other functions (AE processors, safety scientists and safety assessment physicians) in evaluating the safety profile of company compounds of responsibility.
  • Identify potential safety signals and inform the appropriate safety assessment physician of all potentially important cases and issues.
  • Deal with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions.
  • Work actively with high-energy proponent of the company’s commitment to public health.
  • Influence and impact others through clear reasoned argument
  • Help to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.
  • Represents GPVE within areas of responsibility, competence and experience.
  • Ensure tasks are performed in the most efficient manner possible commensurate with quality, accuracy and safety in accordance with company cost effectiveness goals
  • Promote collegiality and teamwork among peers.
  • Develop self and others.
  • Align objectives with organizational goal.
  • Skills : Qualifications

  • MD or Equivalent.
  • Board certification and medical specialty preferred.
  • 2-4 years in clinical practice or relevant setting.
  • 1-3 years in pharmaceutical industry (pharmacovigilance experience preferred) or equivalent.
  • Knowledgeable and skilled in medicine and pharmaceutical product safety.
  • Experience applying medical knowledge to the interpretation of individual case review.
  • Experience with reporting of individual adverse events.
  • Previous experience in the safety field and / or pharmaceutical industry.
  • Experience working in a team environment, including supporting other team members when necessary
  • Demonstrated creative problem solving skills that enact change and drive continuous improvement.
  • Excellent oral, and written English skills
  • Excellent communication, interpersonal and time management skills
  • Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.
  • Ability to build and manage inter-relationships by motivating and inspiring others.
  • Ability to operate with minimal direction.
  • Experience in Argus safety database is preferred.
  • Ability to decide act, connect, collaborate, innovate, improve and grow and engage.
  • Apply
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