Pharmacovigilance Network Specialist

Vertex Inc.•Boston, MA

8d•$82,400 - $123,600•Remote

About The Position

The International Pharmacovigilance (PV) Specialist is responsible for supporting the management of the GPS International PV structure. This role works with a moderate level of supervision and helps troubleshoot problems and improve internal procedures to ensure compliance with applicable regulatory requirements. The company is a global biotechnology firm focused on scientific innovation to create transformative medicines for people with serious diseases.

Requirements

Effectively operates in a matrix environment to support cross-functional initiatives
Ability to multi-task with sound attention to detail
Solid written and verbal communication skills
Ability to work under moderate supervision, as well as in a team setting
Understands established procedures
Ability to adapt and react to change in priorities and effectively manage workload with support from line management
Basic understanding of global PV regulatory requirements
Proficiency in using Microsoft Office applications required (Word, Excel, and PowerPoint)

Responsibilities

Assists with ensuring that all GPS procedures are compliant with global PV regulations
Contributes to vendor oversight activities
Supports the oversight of local Qualified Persons for Pharmacovigilance (QPPVs)
Researches PV regulations and guidelines
Reviews, assesses, and tracks global PV regulatory intelligence
Reviews PV agreements which support local and regional PV requirements
Works cross-functionally to plan and verify safety database configuration compliance based on PV intelligence and geographic expansion activities
Performs compliance impact assessments as assigned
Assists with production of presentations concerning safety issues, initiatives, and projects
Represents GPS and Vertex regarding patient safety related matters as assigned
Regularly responds to cross-functional teams’ and vendor questions
Collaborates and builds/fosters relationships cross-functionally and on a global scale with individuals of all levels
Provides PV information and guidance to cross- functional teams
Collects, analyzes and utilizes data and feedback / shares information to identify opportunities to improve relationships cross-functionally, working effectively and lead business-wide improvements
Liaises between GPS and members of International teams
Communicates and coordinates activities and bridges alignment
Triages and escalates patient safety related matters as appropriate
Proactively raises awareness and promotes GPS activities, policies and best practices
Shares information for innovative corporate improvement projects as endorsed
Performs other duties as assigned