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Senior Medical Director, Benefit-Risk Management

Reference Number: 3692
Location: USA

Our client is a global, research-based biopharmaceutical company. They have asked us to assist them in their search for a Senior Medical Director, Benefit-Risk Management

Major tasks and responsibilities will include:

  • Advises on benefit-risk (B/R) assessments and risk management (RM) strategies in support of drug development programs, new product marketing applications, and marketed products.
  • Works in a collaborative manner with statistical colleagues to develop graphical displays of B/R assessments and advises teams on use of quantitative B/R analysis approaches.
  • Supports preparation and updating of RMPs for assigned products.
  • Supports affiliates with development of local RMPs/annexes.
  • Understands assigned products' pharmacology and B/R profile.
  • Understands precedence analysis and applies it to BRM deliverables.
  • Prepares and reviews B/R and RM sections in clinical development, pharmacovigilance, and regulatory documents.
  • Drives buy-in, adoption, and compliance with BRM processes.
  • Develops risk minimization measures including user testing/human factors testing.
  • Develops US and global implementation strategy for risk minimization programs.
  • Develops effectiveness evaluations for a risk minimization measures and programs
  • Works in a collaborative manner with office of QPPV to ensure affiliate compliance with execution of RM strategies.
  • Ensures development and maintenance of education and communication materials for BRM processes and activities.
  • Evaluates impact of new PV legistlation on BRM activities.
  • Develops and implements policies and procedures relating to BRM that align with the requirements of regulatory authorities, global polices, and best practices
  • Supports preparation of publications relating to BRM processes and activities.
  • Anticipates emerging issues and develops solutions relating to BRM processes and deliverables.
  • Support inspection readiness activities.
  • Updates and aligns SOPs/WIs/processes to ensure seamless execution of BRM activities.
  • Serves as SME to support development of tools and templates to execute BRM processes.

We seek candidates with the following qualifications:

  • An advanced degree (MD or DO) is required. Additional Master of Public Health degree is preferred.
  • Requires 5 to 8 years of Pharmacovigilance experience in the pharmaceutical industry.
  • Must be able to lead cross-functional team in a collaborative environment.
  • Fluency in English, oral and written, required.
  • Must be able to write, review, and provide input on technical documents.
  • Must effectively analyze and guide analysis of clinical data and epidemiological information.
  • Experience in pharmaceutical clinical development highly preferred.

If interested, please email your resume as a Word attachment to us, reference 3692.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.