Global Patient Safety Senior Manager
Assume significant role in RM activities working on unique and complex assignments including performing signal management activities; responding to regulatory agency queries; preparing periodic safety documents (PSURs, RMPs, etc). Work approach will require complex to highly complex decisions to be made to effectively complete tasks. May assume role of Lead for assigned compounds.
While working independently with minimal support from Therapeutic Area Head:
1. Monitor the safety profile of assigned compounds to identify safety signals, and develop and execute a plan for their evaluation.
2. Author regulatory documents for assigned compounds
3. Prepare and deliver presentations at SMT meetings; participate in Dose Escalation meetings
4. Leads other risk management activities as appropriate for assigned compounds.
5. May represent Opth and ID Therapeutic Area for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
6. Actively participate in the development and maintenance of relevant SOPs and supporting documents.
7. Guide process improvement activities within GPS.
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments. Ability to utilize GPS safety system database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) safety findings. Exceptional initiative, creativity and innovation skills with an advanced in-depth and broad knowledge base in field.