Associate Director, Pharmacovigilance Scientist

Location
Cambridge, MA, United States
Posted
Oct 05, 2018
Ref
967183
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Working in our growing Pharmacovigilance team, as an individual contributor PV expert you will provide operational and strategic PV support for bluebird's developmental products in close collaboration with senior PV and Medical staff.

About the role:
  • Oversight of day to day safety monitoring activities and safety operations of clinical trials
  • Provide PV subject matter expertise on Program Teams and other cross-functional platforms throughout the company
  • Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents
  • Participate in writing of aggregate safety reports, e.g., DSURs, PSURs
  • Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
  • Provide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate

About you:
  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
  • Minimum 6 years of pharmaceutical industry experience, including a minimum of 5 years of working directly in PV
  • Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases
  • Extensive PV operations background including case processing, SAE reconciliation, CRF design, protocol review, and ICF maintenance
  • Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
  • 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
  • Ability to execute and follow-through to completion
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent communication skills and ability to influence across multiple functions.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself