Current Job Openings
Pharmacovigilance Manager
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. We are looking for an individual to join our team for a contract position with one of our major clients here in Houston area.
Office Location: Katy Fwy, Houston Texas 77024 (Remote capabilities)
Remote: YES
Pay Rate: $50.00 per hour
Estimated Hours per week: 10-20 hours per week (part-time)
Assignment Duration: 6 months (Planned, may extend)
Responsibilities:
- Pharmacovigilance (PV) Literature search
- Manage interaction with ALSI on PV cases and file cases with FDA.
- Manage training materials for Airgas PV training. Conduct training if live or phone training is required.
- Manage SOP's for all PV activities
- Manage quarterly reports to ALSI
- Conduct reviews of customer complaints to detect PV cases that may have not been reported.
- Assist Local PV officer duties above as well as answering questions from ALSI.
- Create and oversee company wide project to capture customer medical licenses with reporting capabilities
- Assess process(es) in place to manage customer license lists per site, region, division. Determine the most effective system to retrieve and update customer licenses.
- Initiate project charter identifying the scope, objective, and team in Q1.
- Assess current processes throughout the divisions and identify the most suitable application to retrieve a site specific list. Evaluate customer license update possibilities/procedures 1H24.
- Build a framework for reporting in the chosen application or acquire new technology to meet the need 2H24.
- Test, validate, and launch the application to the field 4 Q24
Requirements:
- Bachelor Degree or 15+ years of industry experience
- Excel, FDA CGR Working Knowledge, Intelex, Start Board of Pharmacy Exp
- 10 years or more regulatory/quality experience in the medical/food gas industry
- Must be able to work remotely
- Prior knowledge of 21CFR FDA regulations
- Must have working knowledge of medical device gas and medical gas reporting requirements pertaining to adverse events or quality issues
For immediate consideration, you are welcome to apply directly to our PTS representative Gabrielle.Warner@PTSadvance.com
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