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Medical Director I

Chicago, IL 60614

Posted: 07/01/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 609522 Is job remote?: Yes Country: United States

Job Description


The Global Safety Physician will support the safety team for assigned products and activities, and will have the medical safety expertise to perform obligatory safety functions with oversight from the product-specific Global Safety Officers.

Responsibilities of this role will include: support for global pharmacovigilance of assigned products as needed, including the review and analysis of safety data from clinical studies, the post-marketing setting, and the scientific literature; assistance with signal assessments; assistance with the preparation and review of aggregate reports, core documents, and labelling updates as required; assistance with the preparation and review of regulatory filing dossiers and responses to regulatory authority requests; serving as a safety MD representative for assigned study management teams, including the review of clinical study documents and reports; and providing safety MD representation for publications team meetings and review of publications.

Qualifications:
• MD required; subspeciality focus in neuroscience preferred
• Minimum 5+ years of experience in the pharmaceutical industry or clinical care setting; ideally with 3-5+ years of overall experience specific to pharmacovigilance
• Prior experience in clinical trials (academic and/or industry)
• Knowledge of pre- and post-marketing US and EU regulations
• Flexibility; dependability; strong written and verbal communication skills; ability to work well within a cross-functional team
Pay ranges between $180-205/hr based on experience 
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