Director, Medical Review (Pharmacovigilance)

This role will be responsible for oversight of all activities to support the medical review of the clinical trial and post-marketing individual case safety reports (ICSRs) of adverse events and other safety information reported to Boston Biomedical, Inc..  This person will supervise the physicians (either in-house or with a vendor) who are medically reviewing adverse event and other safety information cases.  He/she will work closely with the Boston Biomedical PV Operations and compliance teams to ensure timely completion of medical review in the larger context of case processing. He/she will work closely with the vendor for outsourced case processing activities, and may provide oversight of outsourced medical review, if applicable. Additionally, he/she will have regular and ad hoc communications with PV Safety Leads and/or the Head of Drug Safety & Pharmacovigilance regarding any medical or compliance issues.

Reporting Relationship: Sr. Director, PV Operations and Compliance

Responsibilities

  • Ensure medical review of all clinical trial and post-marketing adverse events, serious adverse events, and reports of other safety information received by Boston Biomedical, including assessment of seriousness, causality, expectedness, and coding in accordance with regulatory requirements
  • Oversee the Pharmacovigilance (PV) physicians performing medical review (either in-house or with a vendor) by completing quality control (QC) checks of case medical reviews, assessing for trends where medical review can be enhanced, and providing feedback to the medical review physicians
  • Oversee onboarding of new PV physicians and ensure appropriate training. Provide continuing guidance and training to the medical review physicians, as applicable. 
  • Collaborate closely with PV Operations case processing and compliance to ensure that cases are medically reviewed and analyses of similar events (AOSEs) are written, as indicated, according to internal timelines that meet regulatory requirements
  • Identify individual events that may be significant to the safety profile or impact benefit risk.  Communicate immediately these events to the appropriate Program Safety Lead and Head of Drug Safety & Pharmacovigilance 
  • Attend Safety Management Team meetings to participate in signaling reviews, signal assessments and safety reviews.
  • Lead responses to regulatory authority or other stakeholder questions regarding ICSRs or individual case reports.
  • Perform medical review of cases in a back-up capacity as needed 
  • Serve as the subject matter expert (SME) about the medical review process for all internal and external (i.e., with a health authority or vendor) discussions
  • Develop and collect appropriate metrics around medical review for communication to PV Operations and the Head of Drug Safety & Pharmacovigilance
  • Review and update as needed the standard operating procedures (SOPs), work instructions (WIs), data handling conventions, narrative templates and AOSE templates that underlie the medical review activities
  • Contribute medical knowledge and expertise to data handling conventions and collection of safety data.
  • Complete regulatory intelligence activities to ensure that the processes in place at Boston Biomedical reflect the most current regulatory requirements

Qualifications

  • Clinical degree such as an MD, DO, PharmD, NP, PA or RN
  • 5+ years of experience performing medical review and/or case processing of ICSRs
  • Ability to apply clinical knowledge to the medical assessment of safety events and other safety information reported to Boston Biomedical
  • Experience with medical review of Oncology SAEs strongly preferred
  • Strong knowledge of clinical trial and post-marketing case processing and global regulations underlying the medical review process
  • Strong knowledge of MedDRA, working knowledge of safety databases (Argus)
  • Excellent communication and writing skills
  • Capacity to work collaboratively in a fast-paced team environment

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com