International PV Senior Specialist
Core
Supports build-out and management of the global Pharmacovigilance (PV) structure, ensuring compliance with regulatory requirements and overseeing local Responsible Persons for Pharmacovigilance (RPPVs).
Role type
Senior IC Pharmacovigilance Specialist
Builds
Global PV operational structure and compliance frameworks
Domain
Biotechnology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global PV regulatory knowledge, SOP/WI authoring, vendor oversight, regulatory intelligence analysis, contract review, cross-functional collaboration
Preferred skills
Matrix environment operation, autonomous problem solving, presentation of safety initiatives
Technologies
Microsoft Office (Word, Excel, PowerPoint), Argus Global Safety Database
Responsibilities
Ensures GPS procedures comply with global PV regulations; Supports oversight of local RPPVs and key vendors; Reviews and tracks global PV regulatory intelligence; Researches PV regulations and guidelines; Develops and reviews PV agreements and contracts; Acts as business liaison for Argus Global Safety Database configuration compliance; Supports cross-functional geographic expansion initiatives; Reviews and authors Standard Operating Procedures (SOPs) and Work Instructions (WIs); Conducts presentations of safety issues, initiatives and projects; Identifies key departmental needs and provides input on solutions; Represents company regarding patient safety matters.
Seniority
Senior, hands-on IC