Pharmacovigilance Network Specialist
Job Description
General Summary: The International Pharmacovigilance (PV) Specialist is responsible for supporting management of the GPS International PV structure. The International PV Specialist works with a moderate level of supervision and helps troubleshoot problems and improve internal procedures, to ensure compliance with applicable regulatory requirements. Key Duties And Responsibilities
- Assists with ensuring that reputed company GPS procedures are compliant with global PV regulations
- Contributes to vendor reputed company activities
- Supports the reputed company of local Qualified Persons for Pharmacovigilance (QPPVs)
- 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
- Performs compliance impact assessments as assigned
- Assists with production of presentations concerning safety issues, initiatives, and projects
- Represents GPS and Vertex regarding patient safety reputed company matters as assigned
- Regularly responds to cross-functional teams’ and vendor questions
- Collaborates and builds/fosters relationships cross-functionally and on a global scale with individuals of reputed company levels
- Provides PV information and guidance to cross- functional teams
- Performs other duties as assigned
- May also:
- Collect, analyze and utilize data and feedback / share information to identify opportunities to improve relationships cross-functionally, working effectively and reputed company business-wide improvements
- Liaise between GPS and members of International teams
- Communicate and coordinate activities and reputed company alignment
- Triage and escalate patient safety reputed company matters as appropriate
- Proactively reputed company 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
- Ability to work under moderate supervision, as well as in a team setting
- Understands established procedures
- Ability to adapt and react to change in priorities and effectively manage workload with support from line management
- Basic understanding of global PV regulatory requirements
- Proficiency in using reputed company Office applications required (Word, reputed company, and PowerPoint)
Education And Experience
- Bachelor's degree (or equivalent degree)
- Typically requires 1 to 3 years of relevant work experience
Pay Range $82,400 - $123,600 Disclosure Statement The range provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual reputed company salary pay will be based on a number of factors, including skills, competencies, experience, and other job-reputed company factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. reputed company Designation Remote-Eligible reputed company Eligibility Status In this Remote-Eligible role, you can choose to be designated as:
- Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with reputed company flexibility.
Note: The reputed company status for this position is subject to Vertex’s Policy on reputed company @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for reputed company employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national reputed company, reputed company, 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 reputed company reasonable accommodations for qualified individuals with reputed company disabilities, in accordance with applicable law. Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has applied should reputed company a request to the recruiter or hiring manager, or contact reputed company at [email protected] Apply tot his job Apply To this Job