Medical Director

1 day ago


Jersey City, New Jersey, United States Lifelancer Full time
About the Role

We are seeking an experienced Medical Director - Regulatory Affairs and Compliance to join our Clinical Development Team working remotely in the US.

Job Overview

The Medical Director, Drug Safety Pharmacovigilance will be responsible for providing safety strategy, expertise, and guidance to the clinical development and project team for assigned products. This role will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements.

Key Responsibilities
  • Developing Pharmacovigilance Strategy: Lead and support the development of pharmacovigilance strategies and activities to ensure compliance with corporate clinical development and commercial goals.
  • Signal Detection and Evaluation: Conduct signal detection activities, including monitoring, evaluation, interpretation, management, and communication of safety information.
  • Safety Monitoring Team (SMT) Meetings: Responsible for conducting SMT meetings to evaluate risk-benefit for compounds with support from cross-functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings.
  • Medical Safety Review: Conduct medical safety reviews, including causality assessments of all available safety data generated from various sources throughout the development process for assigned compounds/projects.
  • Clinical Document Review: Provide medical expert safety review input into all critical documents for products in clinical development, such as INDs/NDA/BLA submissions, protocols, and amendments.
Requirements
  • MD or MBBS or MD-PhD or equivalent medical degree.
  • 5+ years of pharmaceutical experience in drug safety pharmacovigilance.
  • Strong understanding of pharmacovigilance regulations in the US and EU.
  • Experience in supporting drug safety activities in registrational clinical studies.
  • High level of medical competence with the ability to balance this with industry standards to achieve business goals.
  • Demonstrated skills in scientific analysis and reasoning.
Estimated Salary Range

$150,000 - $200,000 per year.



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