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Medical Director - Illinois, United States - Mindlance
Description
Job Title: Medical Director
Site : Remote
Duration: Up to 12 months + with possible extension
Description:
The Global Safety Contract 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 labeling 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; subspecialty 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
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
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