Responsibilities 

· Safety Intake and properly triage adverse events/product quality complaints/medical inquiries including follow up as needed

· Review individual adverse event reports, including serious cases, prepared by the contracted PV vendor for completeness to ensure cases meet company and regulatory standards before approving for submission to regulatory bodies and safety partners.

· Review Periodic Adverse Drug Event Reports for approved applications prior to submission to FDA to confirm the completeness and accuracy of the information being provided.

· Serve as primary back up for Director of RA for pharmacovigilance activities such as monthly reconciliations with PV vendor and business partners, REMS activities, and Product Reference Tool updates

· Independently prepare:

· Original ANDAs

· Amendments

· Supplements

· Annual Reports

· PADER Reports

Additional types of assignments may be given, as needed 

· Determine Filing Strategy

· Must possess an understanding of regulations and guidances

· Assess Change Controls 

· A minimum of 2 years’ experience in Regulatory Affairs and Pharmacovigilance with a generics company is preferred

· A minimum of a Bachelor’s degree, preferably in Chemistry, Biology, Pharmacy or a related, scientific discipline

Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required 

· A minimum of 2 years’ experience in Regulatory Affairs and Pharmacovigilance with a generics company is preferred

· A minimum of a Bachelor’s degree, preferably in Chemistry, Biology, Pharmacy or a related, scientific discipline

Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required