Associate Director, Global PV Operations - 1453
Ascendis Pharma
Palo Alto, california
The Associate Director, Global PV Operations reports directly to the Head of Global PV Operations. Under the direction of the Head of Global PV Operations, is responsible for all assigned Ascendis Drug Safety PV Operations related activities for all products in the Ascendis portfolio. This individual has accountability for the assigned PV Operations activities in Ascendis.
Key Responsibilities
Support Study Management Teams (SMTs) as an active member representing PV Operations team.
- Participate in the conduct of Sponsored and Investigator Initiated Trials for Ascendis products
- Responsible for the review of study documents including but not limited to Study Protocol, Safety Management Plan (SMPs), Data Management Plan etc.
- Support SAE Reconciliation activities for assigned studies as applicable
- Responsible for study classification (i.e. interventional studies, noninterventional studies, Post Approval Safety Studies (PASS)...