Senior associate, pharmacovigilance - mexico - remote
Worldwide Clinical Trials • ciudad nezahualcóyotl, Mexico
Role Description
What the Senior Associate, Pharmacovigilance does WorldwideResponsible 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. Independently serves as Lead PV Associate on large sized studies/programs that are moderate to complex in scope of work.
What you will do
Author Safety Management Plan for assigned studies
Review incoming SAE data for completeness and accuracy
Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
Generate queries for missing or unclear information and follow-up with sites for resolution
Perform QC of SAEs processed by other PV Associates
Generate regulatory reports and perform safety submissions as needed
What you will bring to the role
Excellent understanding of medical and scientific terminolog...
What you will do
Author Safety Management Plan for assigned studies
Review incoming SAE data for completeness and accuracy
Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
Generate queries for missing or unclear information and follow-up with sites for resolution
Perform QC of SAEs processed by other PV Associates
Generate regulatory reports and perform safety submissions as needed
What you will bring to the role
Excellent understanding of medical and scientific terminolog...