Related skills
argus arisg ctd veevasafety dsur📋 Description
- Support the clinical development team in review of key docs (protocol & ICFs)
- Manage drug safety CROs to ensure expedited reporting & DSURs
- Assist in medical review of adverse event reports; expedite reporting
- Oversee safety data from development to post-approval
- Establish safety strategy for regulatory filings and CTD
- Prepare aggregate safety reports
🎯 Requirements
- Bachelor's degree in a health care discipline; advanced degree preferred
- 10+ years of drug safety and pharmacovigilance experience
- At least 5 years in Clinical Development Safety
- Extensive safety signal evaluation and regulatory liaison
- Experience with safety databases Argus, ArisG, VeevaSafety
- Familiar with CIOMS II reporting and DSURs; MS Office proficiency
🎁 Benefits
- Market leading compensation; salary range $262k-$370k
- 401K with 100% match on first 3% and 50% on next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award
- Hybrid work model; unlimited PTO; parental leave
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Healthcare Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!