International PV Senior Specialist

Vertex Inc.•Boston, MA

13d•$102,600 - $153,800•Remote

About The Position

The International PV Senior Specialist is responsible for supporting the build-out and management of the GPS International PV structure. This role operates with a degree of independence, supporting the troubleshooting of problems and improvement of internal procedures to ensure compliance with applicable regulatory requirements. The 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.

Requirements

Effectively operates in a matrix environment to support cross-functional initiatives
Ability to multi-task with sound attention to detail
Solid written and oral communication skills
Strong sense of responsibility and an ability to work autonomously, as well as acting as a strong team player
Understands established procedures and communicates those procedures to others
Ability to adapt and react to change in priorities and effectively manage workload with support from line management
Maintains a current understanding of global PV regulatory requirements
Ability to apply knowledge to new situations
B.S. (or equivalent degree) and 3-4 years of relevant work experience, or PharmD, M.S.N (or equivalent degree) and 3 – 5 years of relevant work experience
Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

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 safety issues, initiatives and projects
Helps to identify key departmental needs and provides constructive input on solutions
Represents GPS and Vertex regarding patient safety related matters as assigned
Ensures prompt and accurate response to cross-functional teams and vendor questions on a continuous basis
Collaborates and continuously builds and fosters relationships cross-functionally and on a global scale with individuals of all levels
Be knowledgeable about and provide Pharmacovigilance information and guidance to cross-functional teams