Description
Job Description
The Global Safety Officer will be 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. Key responsibilities include:
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- Routine safety surveillance/signal detection
- Labelling
- Medical literature review
- Contribution to/Creation of regulatory responses
- Review of outsourced reports
Qualifications
- 6 - 9 years of experience in reporting/submission of safety information related to drug products
- Must be a Health Care Professional, ideally a Physician
- Excellent verbal and written English communication skills
- Global pharmacovigilance experience
- Consumer health background
- Ability to make quick assessments to meet strict deadlines
- Medical writing/literature review experience