Job Description
Pharmacovigilance (PV) Manager is responsible for maintaining Vertex’s compliance with global Pharmacovigilance regulations for International region. The Manager role works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures. By virtue of their experience, the International PV Manager is expected to provide guidance and leadership and complete work in a resourceful, self-sufficient manner.
Key Responsibilities:
- Act as the Local Safety Responsible/Local Qualified Person for Pharmacovigilance (QPPV) in Saudi Arabia
- Ensures that all PV activities and GPS procedures are compliant with global PV regulations and are in alignment with Regulatory and Commercial Expansion strategies as applicable
- Liaison for local Qualified Persons (QPs) or Responsible Persons (RPs) with GPS globally
- Ensures required GPS contractual agreements are developed and finalized in a timely manner to support local and regional regulations
- Responsible for review and assessment of global PV regulatory intelligence
- Act as business liaison to ensure Argus Global Safety Database configuration compliance based on PV intelligence and geographic expansion activities
- Assists in the training and development of other staff members in key processes and procedures, if required
- Conduct presentations of safety issues, initiatives, and projects
- Provides input on effectiveness of the Quality Management System and when applicable, provides suggestions for improvement
- Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with minimal supervision
- Collaborates and contributes technical expertise to production of various reports to support compliance with global PV activities
- Helps to identify key departmental needs and provides constructive input on solutions
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Represent GPS and Vertex regarding patient safety related matters as assigned
- Ensure prompt and accurate response to cross-functional teams’ and vendor questions on a continuous basis
- Collaborate and continuously build and foster 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
- Performs other duties as assigned
Knowledge and Skills Required:
- Effectively operates in a matrix environment to ensure completion of 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 in a team setting
- Understands established procedures and communicates those procedures to others
- Ability to adapt and react to change in priorities and effectively manage workload
- Supports regulatory inspection and internal/external audit activities when requested
- Maintains a current understanding of global PV regulatory requirements
- Ability to apply knowledge to new situations.
Education and Experience:
- Bachelor’s Degree in Medicine or Pharmacy required.
- Direct pharmacovigilance experience in the industry.
- Licensed by Saudi Commission for Health Specialties.
- Solid knowledge of pharmacovigilance system operations and function.
- Strong knowledge and documentation of education in the field of pharmacovigilance regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing setting.
- Strong operational skills as demonstrated by leading previous projects or functions.
- Excellent oral and written communication skills in English (required) and Arabic (required).
- High ethical standards, including a commitment to Vertex's values and behaviors.
This position is based in KSA and the role is 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 ApplicationAssistance@vrtx.com.
