International PV Senior Specialist

Job Description General Summary: The International PV Senior Specialist is responsible for supporting build-out and management of the GPS International PV structure. The International PV Senior Specialist works with a degree of independence and supports troubleshooting problems and improving internal procedures, to ensure compliance with applicable regulatory requirements. This individual helps ensure that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the International PV Senior Specialist is expected to complete work in a resourceful, self-sufficient manner. Key Duties and Responsibilities: Assists with ensuring that all GPS procedures are compliant with global PV regulations Supports oversight of local Responsible Persons for Pharmacovigilance (RPPVs) and key vendors Reviews, assesses, and tracks global PV regulatory intelligence Researches PV regulations and guidelines Develops and reviews PV agreements and contracts which support local and regional PV requirements Acts as business liaison to ensure Argus Global Safety Database configuration compliance based on PV Intelligence and geographic expansion activities Supports cross-functional geographic expansion initiatives Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with support from line management Conducts presentations of #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)