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Senior Medical Director Pharmacovigilance and Risk Management

Reference Number: 3209
Location: PA

Our client is a global specialty pharmaceutical company. They have asked us to assist them in their search for a Senior Medical Director Pharmacovigilance and Risk Management.

Major tasks and responsibilities will include:

  • Overall responsibility for PVRM physician services including working with international physicians and QPPVs.
  • Oversight for all individual case medical review and periodic report medical review.
  • Reviews the listing and narrative summaries for regulatory submissions including annual reports for NDAs and INDs, and integrated safety summaries.
  • Prepares and reviews of ad hoc documents required in response to requests from the FDA and other regulatory agencies.
  • Oversee assignment of HHEs.
  • Reviews or author all HHEs.
  • Liaises with Quality to obtain necessary information to properly inform the HHE.
  • Attends Tier I market action meetings or Tier II meetings (if necessary).
  • Ensure that the PVRM Department provides customer-focused operational support to the Clinical Development department, clinical teams, and commercial operation within the company to meet corporate goals.
  • Works with internal resources or outsource partners to oversee and manage all drug safety and surveillance activities for clinical trial phases.
  • Function as a member of one or more product development teams.
  • Interacts extensively with cross-functional teams (clinical, commercial and regulatory, etc.) for efficient, high quality drug development.
  • Serves as a member of the Safety Review Board; provide PVRM leadership and administrative support to the Board in its advisory and program support roles.
  • Supervises the signal detection activities related to the company’s products.
  • Utilizes epidemiology tools and medical judgment to conduct ongoing evaluation of potential safety signals for all clinical programs.
  • Provides medical input to the assessment of information, including routine assessments of safety signals and prioritization for full evaluation in partnership with the responsible clinical scientist.
  • Contributes to or supervises product labeling reviews for the company’s products.
  • Supervises the activities and mentor direct reports.
  • Supervises the performance of the company’s drug safety contractors.
  • Represents the VP, PVRM and the Department in roles, meetings, committees, etc. as assigned.
  • Liaises with safety departments.

We seek candidates with the following qualifications:

  • Medical Degree.
  • Minimum of 10 years of pharmaceutical industry experience with 8 years of those in Drug Safety and Pharmacovigilance.
  • Demonstrates ability to exert influence toward goals in a matrix environment.
  • Possesses a sound foundation in clinical medicine and/or drug development combined with the ability to influence with credibility at all levels of the organization.
  • Demonstrates an awareness of Pharmacovigilance regulations and methodology.
  • Demonstrates a solid understanding of scientific methodology in the design, conduct, interpretation and reporting of clinical research projects with emphasis on safety monitoring.
  • Demonstrates knowledge of clinical development process.
  • Proficiency in MS-Office, Outlook and related software.
  • Excellent ability to develop and maintain good working relationships (internal & external).
  • Proficiency with safety databases and/or analytical tools (Signal Detection tools, ARISg, FAERS, Bus. Objects).

 

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 3209. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.