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Manager, Medical Affairs
3 months ago
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:
- Management of adverse drug event reporting and providing accurate/timely submission of reports to appropriate entities.
- Provide support to internal and external customers in the execution of accurate/timely responses to medical information inquiries.
- Review of Bioequivalence studies.
- Performs competitive intelligence research to Sales & Marketing.
- Provides oversight and active management of company’s third party who manages and tracks Pharmacovigilance and Medical Communications.
Knowledge or Experience:
- Possess strong broad pharmaceutical and medical therapy knowledge.
- Strong ability to build relationship and sound working relationships, both internal and external.
- Possess innovative disposition, open-minded, creative, and attention to details.
- Strong computer skills, including Microsoft Office applications, and extensive experience managing electronic databases.
- Strong communication and judgment skills with a proactive attitude to assist and anticipate the needs of the department.
- Ability to work independently, and make decisions, while organizing multiple tasks, and meeting aggressive deadlines.
Minimum Qualifications / Experience:
- 5-10 years in pharmaceutical medicine or clinical practice with medical affairs management.
- Broad knowledge of US requirements for Adverse Events reporting and GCP/ICH/FDA requirements for Bioequivalence Studies, outside the US experience is a plus.
Education / Certifications:
- Specific Advanced Life Sciences Degree (PharmD or RPh) or equivalent experience.
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.
