DRUG SAFETY ASSOCIATE DIRECTOR NEEDED IN CAMBRIDGE, MA!!

Position Summary:
Responsibilities may include medical review of postmarketing and/or clinical trial adverse event reports, analysis of safety data and creation of periodic safety reports and other ad hoc reports, provision of support to global pharmacovigilance, and service as a medical resource to the department.

" Ensure compliance with corporate and departmental SOPs.
" Provide advice regarding investigations of special questions regarding safety of investigational and marketed products.
" May perform medical review of postmarketing and clinical trail adverse event information, and oversee generation of medical narratives in the safety database system.
" May provide advice concerning medical matters related to safety of drug in clinical trials.
" May provide support to pharmacovigilance and Continuous Quality Improvement (CQI) activities.
" May ensure adequacy of recording, summarization, and handling of adverse events for marketed Biogen Idec products including decisions on seriousness and expectedness.
" May ensure due diligence in characterizing adverse events.
" Provide clinical/regulatory expertise to personnel within the department and to outside groups.
" May ensure adequacy of recording, summarizing, and handling of serious adverse events from Biogen clinical trials including decisions on seriousness, expectedness, and causality.
" May ensure accurate coding of adverse events and serve as a resource to the coding staff.
" May ensure maintenance and update of existing informational materials.
" Ability to manage/supervise their own activities in a high-pressure, fast-paced and changing environment to ensure objectives are met in a timely manner and within budget.
" Ability to interact effectively with staff of multiple disciplines within the company domestically.
" Possess knowledge of cGCP regulations, 21CFR Part 11, and HIPAA and follow appropriately.
" Ability to effectively train staff members.
" Graduate of a recognized, accredited medical school.
" Minimum of 3 years experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.
Ideal:
" 5 years experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry.


Technical Skills:
" Working knowledge of Microsoft software systems.
" Working knowledge of Oracle AERS or similar safety database.
" Working knowledge of Business Objects or similar reporting tool.