1 Sopwi Authoring Jobs

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5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: You will be responsible for ensuring the safety and effectiveness of pharmaceuticals through signal detection, risk management, and regulatory compliance. This includes preparing and reviewing Risk Management Plans (RMPs), aggregate reports, and signal detection reports. Your role will also involve training, authoring SOPs/WIs, and ensuring compliance with Good Pharmacovigilance Practices. Key Responsibilities: - Signal Detection and management - Drafting or reviewing signal detection reports - Preparation and review of Risk Management Plans (RMP) - Preparation and review of Risk Management Plan aggregate reports (PADERs/PSURs) - Handling additional Risk Minimization Measures ...

Posted 1 month ago

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