165 applicants

Company

Original Job Post

Vertex Pharmaceuticals · 2 days ago

Specialist, Patient Safety Quality, Standards & Training

Boston, MA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $124K/yr

2+ years exp

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Responsibilities

Participates in the implementation of quality and compliance activities within GPS. These activities include, but are not limited to, the following: training, GPS deviation investigation management, GPS Corrective Action Preventative Action (CAPA) management, GPS documentation quality review, GPS document management, and Audit/Inspection Readiness

Contributes to the Pharmacovigilance System Master File (PSMF) as assigned

Helps to facilitate and provide quality insight into GPS deviation investigations and CAPAs

Reviews and maintains Pharmacovigilance Agreements and Contracts and coordinates associated relationships with Vendors/Business Partners as assigned

Contributes to the development and the review of Standard Operating Procedures and Work Instructions

Helps to create and conduct presentations of quality or compliance issues, initiatives, and projects

Collaborates with stakeholders in the remediation of identified compliance risks

Generates and presents quality metrics to management and other stakeholders

Works collaboratively to ensure completion of quality and compliance initiatives

Provides support, as requested, in the preparation, facilitation, and close-out of audits and inspections

Responsible for supporting management with inspection readiness activities

Participates in safety-related projects/teams as assigned

Provides support to all GPS business units, as requested

Qualification

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PharmacovigilanceRegulatory complianceMicrosoft officeCommunicationAttention to detailProblem-solving

Required

Bachelor's degree in a scientific or allied health field (or equivalent degree)

Typically requires 2 years of experience or the equivalent combination of education and experience

Sound ability to communicate effectively in a matrix environment

Solid written and oral communication skills

Sound attention to detail

Displays ability to understand established procedures and communicate those procedures to others

Demonstrates a basic understanding of quality and regulatory compliance as well as application of these concepts to Pharmacovigilance

Effectively communicates issues regarding quality or compliance concerns to internal and external stakeholders

Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Benefits

Medical, dental, and vision benefits

Generous paid time off

Educational assistance programs including student loan repayment

Commuting subsidy

Matching charitable donations

401(k)

Company

Vertex Pharmaceuticals

Glassdoor

4.2

Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.

Founded in 1989

Boston, Massachusetts, USA

1,001-5,000 employees

http://www.vrtx.com

H1B Sponsorship

Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2020 (1)