Johnson & Johnson Careers

Policy Implementation and Pharmacovigilance System Master File Specialist

Warsaw, Poland
R&D


Job Description

Requisition ID: 1905738258W

The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center  #Cobic in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
 
Policy Implementation and Pharmacovigilance System Master File Specialist
Location: Warszawa, Poland
 
The Product Vigilance Policy Implementation and Pharmacovigilance System Master File Specialist is responsible for monitoring, entering to the tracking tool and performing first steps of triage of new and updated global and regional regulations that impact global Product Vigilance (PV). This position acts as a key liaison for OCMS with internal and external stakeholders on PV-specific regulatory topics and supports efforts to implement regulations that impact global PV operations. In addition, the Specialist is responsible for providing support to maintenance of the PSMF and other operational activities related to PV Policy and QPPV office, including participating in internal working groups as needed.
 
Main Tasks:
  • Enabling proactive compliance with global PV regulations through:
    • Monitoring of new and updated regulations
    • Entering regulations to the designated tracker and recording triage results
    • Supporting the coordination of cross-functional teams to review and assess requirements on PV regulations and identify gaps impacting the global and local PV system
    • Driving timely development of key deliverables of the QPPV office by planning and facilitating productive working sessions and follow up on actions
    • Development of dashboards, storyboards, scorecards to increase visibility and clarity of projects, including key achievements, issues, mitigation strategies, and goal tracking
    • Maintaining visibility on day-to-day activities with project teams
    • Ensuring all requirements and deliverables/outcomes are documented and retrievable for inspection readiness purposes
  • PSMF activities:
    • Provide support to the collection of inputs to PSMF from stakeholders
    • Provide support for inclusion of stakeholder’s inputs into the PSMF
    • Develop and circulate updates to management concerning timeliness and quality of the stakeholder’s contributions.

Qualifications

Crucial Requirements for Candidates:

This position is responsible for providing support in projects, including content, connections with stakeholders, business units and system tools. Skills at assessing data and information, preparing messages, and support execution of strategy are required. The Specialist must understand global pharmacovigilance system of J&J Consumer sector and have basic knowledge of PV-related end-to-end processes within OCMS and internal and external stakeholders and
 be able to: 
  • Have ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders
  • Understand stakeholder/customer needs, be able to network building alliances and influence other groups
  • Develop effective and highly communicative relationships across highly complex organizations of multifunctional personnel
  • Exercise excellent judgment in assessing priorities and management of projects

In Return, We Offer:

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.
  • Many employees benefits.
If you are interested in this role or you want to refer a candidate that fulfills the requirements set above, do not hesitate to send us your CV in English via MyNextStep.jnj.com or EmployeeReferrals.jnj.com.

Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
R&D
Requisition ID
1905738258W