Associate Director Aggregate Safety Reporting
R&D focused Top Ten Pharmaceutical company that strives to create an atmosphere for innovation while encouraging employees to maximize their potential. This role will remain fully REMOTE post Covid. The Associate Director Aggregate Safety Reporting will manage and direct the ASR workstreams to be on time and support delegated products.
The Associate Director Aggregate Safety Reporting will be responsible for:
- Responsible for strategic oversight and delivery of aggregate safety reports (ASRs) and risk management plan (RMP) documents for investigational and marketed products
- Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for aggregate safety reports
- Conducts QC sampling of ASRs of assigned products to ensure high quality documents are being generated by vendor resources
- Tracks KPIs for ASR production and quality
- Oversees vendor resources
- Bachelor's degree required, advanced degrees preferred
- 5 years of Pharmacovigilance experience
- Competitive Salary
- Yearly Bonus
- 401k with matching
Are you ready to be an Associate Director from home? Apply now!