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Senior Director, Pharmacovigilance

Company: bluebird bio
Location: Somerville
Posted on: September 20, 2023

Job Description:

The bluebird bio pharmacovigilance group is a small but mighty team of physicians and scientists that oversee all aspects of our patients' safety. We are collaborative, supportive, and thoughtful.
You'll help to bring more patients their bluebird days by:

  • Overseeing day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product
  • Providing PV subject matter expertise on Program Teams and other cross-functional platforms throughout the company
  • Facilitating cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
  • Reviewing and providing PV input for development of protocols, IBs, CSRs and other relevant study documents
  • Participating in writing of aggregate safety reports, e.g., DSURs, PSURs
  • Providing subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate
  • Acting as primary oversight of PV CROs

    You're the bird we're looking for if you have:

    • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
    • Minimum 10 years' pharmaceutical industry experience, including a minimum of 5 years' experience as PV Scientist
    • Knowledge of MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases
    • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
    • Experience in the preparation and authoring of pre- and post- aggregate safety reports
    • Thorough understanding of the drug development process and context applicable to safety surveillance activities

      Compensation & Benefits
      We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $240,000 - $348,000. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as 28 paid holidays, including 2 company shutdowns.

Keywords: bluebird bio, Somerville , Senior Director, Pharmacovigilance, Executive , Somerville, Massachusetts

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