Sr. Associate, Risk Mgt, Consulting
Pfizer
Thessaloniki Chortiatis, Greece
πριν από 1 μέρα

The Enterprise Platforms & Security (EP&S) team delivers the following capabilities for Pfizer. Business application platforms supporting Pfizer’s enterprise application and critical business processes.

Infrastructure allowing business traffic to travel where it needs to go, internally and externally, along with the appropriate access controls.

EP&S secures Pfizer's most important information assets through world class controls and protections and enables Pfizer's business results by making security an enabler and not a roadblock to achieving business results.

The Compliance & Regulatory Risk Management (CRRM) organization works with a global stakeholder community to incorporate legal, regulatory, and corporate policy requirements into solutions, services, and daily Digital operational activities.

CRRM strives to make compliance simple and to develop logical, robust, and cost-effective compliant processes and services across Digital.

The Sr. Associate Risk Management Consulting role will collaborate with Digital partners to ensure Digital services and solutions are planned, designed, deployed, operated, and supported in a manner which meets Digital general controls and regulatory requirements.

The position is an individual contributor role with leadership and engagement with cross functional internal colleagues and external partners (under direct oversight).

ROLE RESPONSIBILITIES :

Under direct oversight this role will have the following primary responsibilities :

  • Deliver risk management and compliance services to assigned Digital lines
  • Guides and supports Digital projects with compliance activities such as Solution Profiles, Compliance Assessments, Requirements and test scripts, Validation plans / protocols and reports.
  • Review and approve Solution Development Life Cycle (SDLC- Waterfall / Agile methodology) deliverables or change management deliverables
  • Works closely with Digital Project Manager, Digital global solution teams and collaborates with associated business groups to ensure that Digital systems are developed and managed in accordance with business and regulatory needs.
  • Drives consistently high standards by assuring compliance with policies, regulations, guidelines, and procedures.
  • Establishes strong relationships with project teams and project leadership to ensure there is effective collaboration and communication
  • Assure audit / inspection awareness and preparedness
  • Support audits and inspections of Digital (prior, during, and post); Work with Digital customers on the remediation of audit / inspection commitments and tracking of remediation status
  • Support the monitoring of Digital process execution to identify targeted continuous improvement efforts to improve operational process effectiveness and control execution
  • Assist with defined compliance strategic projects / initiatives, and manage the associated records and activity tracking
  • Support multiple compliance related projects and initiatives simultaneously
  • BASIC QUALIFICATIONS :

  • BS required; Information Security, Information Technology, Computer Science, Engineering, Science (Biology, Chemistry, etc.
  • or related majors preferred

  • 3+ years of experience in pharmaceutical or other regulated industry preferably with GxP computer system validation experience.
  • Excellent oral and written communications.
  • Ability to proactively solve complex problems both individually and as part of a team
  • Ability to work independently and manage multiple priorities
  • PREFERRED QUALIFICATIONS :

  • Experience in cGMP’s and 21 CFR Part 11 in an FDA, MHRA, EMA or other regulated environment.
  • Experience working through a highly matrixed organization to support and drive key initiatives.
  • Experience with the Microsoft Office suite, basic skills managing SharePoint sites and basic understanding of Visualization and Reporting tools.
  • Basic understanding of Agile methodology.
  • REQUIRED APPTITUDES :

  • Quick to establish trust and respect
  • Action oriented and energetic
  • Resourceful and avid Lerner
  • Easily make connections
  • Effective oral, written, and interpersonal communications skills are required as well as organizational, planning, and administrative abilities and the ability to coordinate multiple complex projects simultaneously
  • NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Domestic and International travel of 10% (as required).
  • Work Location Assignment : Flexible

    Purpose

    Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values : courage, joy, equity and excellence.

    Our breakthrough culture lends itself to our dedication to transforming millions of lives.

    Digital Transformation Strategy

    One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

    Flexibility

    We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

    Let’s start the conversation!

    Equal Employment Opportunity

    We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve.

    Together, we continue to build a culture that encourages, supports and empowers our employees.

    Information & Business Tech

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