. The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety... in the development pipeline and on the market. Ensures the implementation and governance of a compliant Pharmacovigilance...
This is what you will do: The individual is accountable to the Global Safety Head for the safety strategy, delivery... a team of safety physicians and / or scientists. They will be required at times to deputize for the Global Safety Head. The...
of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely... expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development...
, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the Head of Medical... across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents...
: Advance the objectives and vision of the Head of Regulatory Ensure project management support and facilitation of the... and tracking of required actions until completion Serve as a strategic thought partner to the Head of Regulatory and Head...
Relationship Management (FSP) based in Cambridge, MA reporting to the Head Partnership Health and Supplier Management. At Takeda..., pharmacovigilance, etc.) to enable meaningful dialogue within Takeda and with partners. Proven experience in Alliance/Partnership...
Clinical Science Head to provide strategic clinical input on assigned clinical studies. Leads the Global Development Team... with Pharmacovigilance and Medical Monitor of record for assigned compounds. Oversees and leads all clinical science activities involved...
and risk-benefit assessments supported by Pharmacovigilance and Clinical Science; Is accountable for the timely delivery... where required. When required, can deputize for the Head of ECDO and act as ECDO representative in Bayer internal governance bodies...
manner to contribute to continuous signal detection and management process Collaborate with other pharmacovigilance... leadership of Head of Medical Review Participate in process improvements for the Medical Review team Maintain close...