International Pharmacovigilance (PV) Senior Specialist

Job Description

General Summary:

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.

Key Duties and 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

May also:

• 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

Knowledge and Skills:

• 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)

Education and Experience:

• 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).

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. 

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]