Takeda Pharmaceuticals North America has built a solid foundation on successful products, principles, people, and research.
We currently have the following position available in Deerfield, IL:
Associate Medical Director/Medical Director, Pharmacovigilance
“Please note that the requirements specified in this posting are the basic qualifications required for the Associate Medical Director position; however, job title will be dependent on the candidate’s level of experience in those requirements.”
RESPONSIBILITIES:
Perform activities required to serve as Global Safety Lead physician:
Act as PV GDT member and RDT member and lead the Global Safety Team
Review and oversight of all safety data, including non-clinical and clinical, for the product
Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities for the product globally.
This includes the authorship of the DCSI and Expectedness List for the compound.
Interactions with external experts and regulatory agencies
Review of safety data, contribute to decision on dose selection in first-in-man studies and participate in dose escalation decisions
Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
Review or generation of monthly safety reports for signal detection, medical review of cases and authorship and sign-off of analysis of similar event reports.
Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators.
Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
Oversight of selection of members, set up and conduct of DSM and Advisory Board activities.
Conduct aggregate analysis of safety data and ensure dissemination and communication regarding emerging safety signals to senior management in TGRD and TPC
Perform activities required to serve as regional PV physician:
Review of all local cases for the designated products
Assist with activities related to local regulatory agency interactions if required
Working knowledge and familiarity with clinical protocols, SAPs, clinical study reports and periodic reports for the product.
Member of safety working group and participate in compilation and review of data to be used by the group.
Maintain professional knowledge and accreditation by active participation in continuing medical education activities.