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Regulatory Affairs Associate - Pharmacovigilance
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Full-time
- Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices.
- Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.
- As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009.
- Processes adverse event reports (ADE) and medical device adverse event reports (MDR) from clinical trials and from marketed products in accordance with company procedures and regulatory requirements.
- Provides support to the Regulatory Affairs Department by assisting with submitting establishment renewal/registration/updates required through Center for Drug Evaluation and Research - CDER Direct.
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