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Sagent Pharmaceuticals - Schaumburg, IL
Manager, Medical Affairs
Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.
The Manager of Medical Affairs is responsible for triaging and responding to medical information inquiries, including the management of company Adverse Event Reporting System (AERS) database, to result in enhanced AERS to meet increasing product launches and post-marketing surveillances. Partners across the business to support Quality and Sales/Marketing groups in the understanding and execution of safety assessments, and managing a compliant product safety database, with the aim to building technical/medical/clinical background within the company. Supports leadership in maintaining the company’s compliance status, with respect to Pharmacovigilance requirements, and ensuring safe patient outcomes for all company customers.
Manage the FDA Postmarketing Drug Safety Inspections.
Literature searches on Sagent owned ANDA drug products for Adverse Events.
Key Duties & Responsibilities:
Knowledge or Experience:
Minimum Qualifications / Experience:
Education / Certifications:
Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.
Full Time
Transportation
$129k-162k (estimate)
06/24/2024
08/23/2024
sagentpharma.com
SCHAUMBURG, IL
200 - 500
2016
MITCH ESTRADA
$200M - $500M
Transportation
SAGENT Pharmaceuticals is a forward-thinking specialty injectables company which offers a completely different business model from product development through delivery. We're built differently - around customers. We act differently - listening first, responding quickly. We perform differently - with a commitment to innovation, efficiency and safety. To further discover injectables excellence from your sustainable partner, SAGENT, please visit www.sagentpharma.com.