What the Associate II, Pharmacovigilance does at Worldwide

Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff.

What you will do

• Author Safety Management Plan for assigned studies
• Attend and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and perform safety submissions as needed

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