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Global Safety Physician/Medical Monitor (Science & Biotech)
Lexington, MA 02421
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Oct 03, 2019
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Job Description

Our client, a growing pharmaceutical company, is currently hiring and growing the team! This position, the Senior Director, Global Safety Officer/Physician/Medical Monitor, is responsible for:
• Management and oversite of a Pharmacovigilance vendor
• Single point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments
• Performs Medical Review of adverse event reports including but not limited to all serious, events of interest, and expedited individual case safety reports ensuring that appropriate medical interpretation, consistency and quality are applied to adverse event case assessment.
• Generates or assists with input to Analysis of Similar Events
• Participates in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development
• Performs review of coding (eg. reaction, suspect/concomitant product, indication, laboratory data, medical history)
• Provides support for investigator brochures, protocols, informed consents, final study reports, as appropriate.
• Provides medical guidance for aggregate reports.
• Contributes to safety issue evaluation and management for the life cycle of product.
• Contributes to signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
• Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development and updates/maintenance of expectedness guides.
• Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, and proposed risk mitigation strategies for discussion at internal meetings
• Assessment of benefit-risk information
• Medical evaluation of Individual Case Safety Reports (ICSR) and Aggregate reports
• Evaluation of safety signals
• Formulation of responses to regulatory inquiries
• Preparation and contribution to regulatory documents

This individual will be recognized as an expert within the organization. Anticipates challenges, recommends process, product or service improvements.

A key success factor will be the ability to manage and supervise external CROs and can operates with no supervision in a complex environment.

Medical licensure and Board certification preferred. 5+ years’ pharmacovigilance experience in drug development pharma/biotech industry. Experience with FDA and working with regulatory groups preferred. Previous experience with risk mitigation strategies preferred. Experience specific to autoimmune and autoinflammatory conditions preferred but not required.