Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader. Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval).
Develops and is responsible for key internal safety documents from the formation of the GPT/GBT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent ...
Title: Senior Clinical Study Manager
Company: Pharmaceutical Company
Location: Northern NJ
Status: Full-time consulting engagement – 40 hours/week
Length: Long term assignment; initial term 1 year
Our Client is a global biopharmaceutical company committed to improving the lives of patients worldwide. Their mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of ...
Our client, a fast paced, growing pharmaceutical company in Central NJ is seeking a Safety Data Specialist for about 6 months. This position pays up to $47/hour, depending upon experience.
Job Role:
• Responsible for collection and processing of spontaneous and clinical trial adverse event and pregnancy reports, which includes data entry and verification of information into the safety database.
• Responsible for medical evaluation of relevant reports, which includes narrative generation, ...
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