Medical Affairs Manager Sagent Pharmaceuticals

Department:
Medical Affairs

Reports To:
Medical Director, Medical Affairs

Classification:
Exempt

Basic Function:
The Medical Affairs Manager would be responsible for triaging and responding to medical information inquiries and managing of corporate Adverse Event Reporting System (AERS) database with adherence to the AERS SOP, to result in enhanced AERS to meet increasing product launches and postmarketing surveillances.

Education/Work Experience:
- Advanced Life Sciences Degree ( PharmD. or R.Ph) or equivalent experience.
- Extensive knowledge of pharmaceuticals and medical therapeutics.
- 3 -7 years in pharmaceutical medicine or clinical practice with medical affairs management.
- Broad knowledge of FDA requirements for Adverse Events reporting and GCP/ICH/FDA requirements for Bioequivalence Studies.
Excellent collaboration skills and experience working across functions to achieve results.

Principal Accountabilities:
- Promptly triage and respond to all medical information inquiries, and forward all received product complaint issues to Quality Assurance Department.
- Ensure corporate stringent pharmacovigilance system with adherence to Adverse Event Reports (AERs) SOP and steadily research published medical literature for Post-Marketing surveillance for drug safety.
- Coordination and data entry of adverse event related information, including but not limited to case file creation, narrative writing and coding using the MedDRA Coding Dictionary.
- Ensure that all AERs are reported to MedWatch within defined timeframes as per FDA.
- Assist Medical Director in screening and selecting fitting CROs for Bioequivalence Studies and to work cooperatively with corporate partners on joint venture Bioequivalence Studies.

Specific Technical/Job-Related Skills:
- Possess strong broad pharmaceutical and medical therapy knowledge.
- Strong ability to build relationship and sound working relationships, both internal and external.
- Possess innovation 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 while organizing multiple tasks and meeting aggressive deadlines.

Location:	1901 North Roselle Road Suite 700 Schaumburg, IL 60195 United States