International Pharmacovigilance (PV) Senior Specialist

Vertex Pharmaceuticals

3d•Remote

About The Position

The International Pharmacovigilance (PV) Senior Specialist is responsible for supporting management of the GPS International PV structure. The International PV Specialist works with a degree of independence and supports troubleshooting problems and improving internal procedures, to ensure compliance with applicable regulatory requirements.

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
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
Proficiency in using Microsoft Office applications required (Word, Excel, and PowerPoint)
Health care professional with a university degree (i.e., third level qualification) in life sciences or allied health fields required
Significant years of direct pharmacovigilance experience
Strong knowledge of Brazil & LATAM pharmacovigilance regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing approval setting
Excellent oral and written communication skills in English (required), Spanish (preferred) , and Brazilian Portuguese (required).

Responsibilities

Assists with ensuring that all GPS procedures are compliant with global PV regulations
Supports the oversight of local Responsible Persons for Pharmacovigilance (RPPVs) and key vendors
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
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
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
Helps to identify key departmental needs and provides constructive input on solutions
Collect, analyze and utilize data and feedback / share information to identify opportunities to improve relationships cross-functionally, working effectively and lead business-wide improvements
Liaise between GPS and members of International teams
Communicate and coordinate activities and bridge alignment
Triage and escalate patient safety related matters as appropriate
Proactively raise awareness and promote GPS activities, policies and best practices
Share information for innovative corporate improvement projects as endorsed