Associate Director, PV Sciences

We are seeking an experienced Senior Pharmacovigilance (PV) Scientist to join Boston Biomedical Drug Safety and Pharmacovigilance. In this exciting and challenging role, you will work collaboratively with the Program Safety Lead and other PV Scientists and Physicians and play a leading role in performing PV activities for your assigned drug project(s).  You may also have the opportunity to work as a Program Safety Lead, depending on your prior experience.  Your ability to work collaboratively will facilitate cross-functional engagement with colleagues from across the Boston Biomedical organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, and Biostatistics.

Responsibilities

Medical Safety

  • Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety
  • Assist in signal detection activities including data assembly, signal validation, and signal evaluation
  • Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities
  • Participate in aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support)
  • Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings
  • Engage with team and support all activities required for presentation to the Boston Biomedical cross-functional, senior level, Oncology Safety Committee
  • Represent PV Medical Safety on cross-functional program and project teams
  • Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with Program Safety Lead, including communication with internal and cross-functional team members, submission of data requests, and 
  • Review program Safety Management Plans
  • Serve as a subject matter expert in Pharmacovigilance within the assigned program as well as the larger Boston Biomedical organization (R&D and Commercial)
  • Note:  This position may assume Program Safety Lead responsibilities, depending on prior experience and nature of program to be manage

Other Activities (as requested)

  • Develop Standard Operating Procedures, Work Instructions, and other controlled documents
  • Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities
  • Support collaboration with external partners

Qualifications

  • Minimum of Bachelor’s level degree in a health care/life sciences related field, with Master’s or other graduate degree preferred
  • Minimum 12 years’ experience as a PV Scientist in the pharmaceutical industry or equivalent setting
  • Prior experience in oncology strongly preferred
  • Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products 
  • Prior experience with Argus required
  • Ability to work independently and productively and set priorities across multiple projects with little supervision
  • Excellent interpersonal skills with demonstrated ability to work in a multi-disciplinary setting and foster teamwork
  • Strong communication skills with excellent written and spoken English

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com