Related skills
pharmacovigilance safety_signal_evaluation ctd📋 Description
- Oversight of safety profile from development to post-approval; manage CROs and partners.
- Chair Safety Management Committee; identify emerging safety trends and actions.
- Define safety strategy for MAAs CTD documents; engage regulators and respond to inquiries.
- Review key documents with clinical team, including protocols and ICFs, for safety relevance.
- Manage drug safety CROs for DSURs and expedited reporting; align with KPIs.
- Develop safety assessments and benefit risk analyses for internal and regulatory use.
🎯 Requirements
- Medical Degree
- 10+ years of drug safety and pharmacovigilance experience
- Experience in safety signal evaluation and cross-functional collaboration
- Experience with regulatory submissions for NDAs EU MAAs and other reviews
- Clinical development and post marketing safety experience
🎁 Benefits
- Market-leading compensation
- 401K with employer match on the first 3 and 50% on the next 2
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with 2500 award for hired referrals
- Comprehensive health care with 100% premiums covered
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!