International PV Senior Specialist

Job Description

General Summary:

TheInternational 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 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

Knowledge and Skills:

• Effectively operates in a matrix environment to support cross-functional initiatives
• Abilityto multi-task with sound attention to detail
• Solidwritten 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

Education and Experience:

• 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
• Proficiencyin using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Pay Range:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as: 
1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2.    Hybrid: work remotely up to two days per week; or select
3.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

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