Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information related to drug products from a variety of sources (clinical trial, spontaneous, literature), both U.S. and foreign, in compliance with SOPs, US regulations, and international regulations. This position is also responsible for self-initiated quality review within each distinct process step. Experience: 6 to 9 years.
Routine safety surveillance/signal detection
Labelling
Medical literature review
Contribution to/Creation of regulatory responses
Review of outsourced reports
Excellent verbal and written English communication skills
Global pharmacovigilance experience
Consumer health background
Flexible to working with many different compounds
Ability to make quick assessments to meet strict deadlines
Medical writing/literature review experience
Education:
Health care professional - PharmD or Physician