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Medical Director - Safety Evaluation

Reference Number: 2929
Location: NY

Our client is a rapidly growing biotechnology company.  They have asked us to assist them in their search for a Medical Director - Safety Evaluation.

The Medical Director – Safety Evaluation is responsible for the accurate and timely assessment of product safety information and medical interpretation of adverse events at the case level.  The Medical Director supports risk management in analysis of signal detection efforts for assigned products or indications.  This individual provides support to the department head and drives pharmacovigilance efforts.

Major tasks and responsibilities will include:

  • Leads in ongoing aggregate review and assessment of product safety data and signal investigation for assigned products or individual product indications.
  • Assesses seriousness, expectedness and medical accuracy of individual case reports.
  • Manages medical triage of serious and non-serious cases, and performs medical review for single cases.
  • Assists in interpretation of clinical study data, and clinical epidemiology studies.
  • Responsible for oversight of clinical trial safety for assigned trials.
  • Participates in decision making process for assigned life cycle management program teams.
  • Participates in weekly medical case review meetings, monthly signaling meetings, and other safety committee meetings with Licensing Partners as required by individual agreements.
  • Develops processes and procedures for identifying and evaluating risk management issues for compounds in development.
  • Effectively coordinates and manages available resources in developing and delivering high-quality risk management documents and deliverables to agreed timelines.
  • Ensures compliance with regulatory standards and guidelines and corporate SOP’s as they relate to Drug Safety and Risk Management.
  • May serve as Drug Safety medical advisor for selected drug development programs and may represent Drug Safety on program teams.
  • Leads medical expertise and judgment to all safety surveillance activities, including periodic report production review and signal detection/investigation.
  • Leads interpretation of safety-related data, determines significance and implication of findings and communication of conclusions.
  • Assists with training of Drug Safety Associates.
  • May assist with talent recruitment.

We seek candidates with the following qualifications:

  • MD required, preferably with residency in Neurology.
  • At least two years of clinical experience post-registration/certification.
  • Three to five years of progressive experience in pharmaceutical or biotech industry or academia.
  • Expert knowledge of risk management and experience supporting risk management.
  • Direct experience in drug safety is desirable.
  • Must possess knowledge of pre and post marketing Global regulations.
  • A proven ability to build productive relationships and teams both internally and externally.
  • Must be proficient in MS Office Suite.
  • Strong leadership and organizational skills.
  • Excellent oral and written communication skills and presentation skills.
  • Problem solver with high degree of initiative and independence.
  • Excellent project and time management as well as strategic planning skills.
  • Ability to analyze complex scientific concepts and to translate into a business language.
  • Able to work effectively with outside service providers.
  • Ability to maintain high level of ethical and compliancy standards.
  • Demonstrated ability to stay abreast of trends and new information in the profession
  • Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2929. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.