[Hiring] International Pharmacovigilance Senior Specialist @Vertex Inc.

Role Description

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.

• 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

Qualifications

• 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)

Requirements

• 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)

Benefits

• Remote-Eligible
• Flexibility to choose designation as Remote, Hybrid, or On-Site
• Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time

Company Description

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].