Job Description
Job Summary
Senior Drug Safety, Pharmacovigilance – responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines, company SOPs and project instructions. Serves independently as Lead PV Associate on large studies or programs that are moderate to complex. Provides mentorship and leadership with minimal supervision.
Key Responsibilities
- 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 QA/QC of SAEs processed by other PV Associates
- Generate regulatory reports and perform safety submissions as needed