Gerente de Farmacovigilância - Sao Paulo, Brasil - Johnson & Johnson

Johnson & Johnson
Johnson & Johnson
Empresa verificada
Sao Paulo, Brasil

há 1 mês

Ana Silva

Postado por:

Ana Silva

beBee Recruiter
Descrição

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.


PRINCIPAL RESPONSIBILITIES:


  • Serve as a Member of the Scientific Affairs Organization;
  • The LSO has a direct reporting line into the Medical Director of the LOC for the local PV system;
  • Act as local nominated contact for PV.;
  • Have an oversight of all PV activities performed in Brazil;
  • Alert the Country Medical Director and Regional PV Sr Manager about any safety related issues without delay;
  • Ensuring that the LOC PV activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners;
  • To be involved in the communication of PV topics with local Health Authority (ANVISA) and coordinate answers in cooperation with Local, Regional PV and Global PV teams;
  • Drive and continuously improve compliance for products by proactively identifying compliance risk areas and managing the investigation of root causes contributing to the compliance issue, and development and accurate/timely implementation of corrective and preventative action plans;
  • Participate, contribute and where appropriate lead local, regional and global projects;
  • Ensure best practices and lessons learned are shared at Area, Region and Global Level, when appropriate;
  • Collaborate with compliance groups, case management teams to ensure accurate oversight information is provided to senior stakeholders;
  • Ensure PV review of the multicountry company activities generating patient data (including clinical research, other medical affairs activities, Market Research, PSP...);
  • Ensure adequate preparation for Inspection readiness;
  • Support implementation of PV systems;
  • Present the voice of the LOC/Area/Business unit to Regional and Global PV team.
  • Provide advice and feedback to local team;
  • Coach local team in the implementation of local business unit's strategies
  • Establish a proactive compliance culture;
  • Ensure PV Brazil budget is under control/flat;

ESSENTIAL KNOWLEDGE & SKILLS:

General knowledge on healthcare and safety

  • Knowledge in Medical/Health Sciences required;
  • Knowledge of local/global legal requirements;
  • Knowledge about local business models and local legal requirements;
  • Comprehensive knowledge of global, Regional Standard Operating Procedures (SOPs);
  • Demonstrable insight to the implementation PV regulatory requirements for medicinals, devices and cosmetics with knowledge of Global aspects of drug safety, including International AE reporting requirements and relevant country
- specific variations Leadership & People Management;

  • Proven leadership and management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment;
  • Excellent people management, negotiation skills and leadership in coaching people in influencing internal and external partners;
  • The ability to operate autonomously without direct supervision;
  • Demonstrated initiative and results orientation;
  • Analytical, and process minded with a systematic and orderly approach.

Qualifications:


  • Degree qualified ideally in life sciences;
  • Qualification in Medical/ Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management;
  • Expertise in safety regulations;
  • Experience of leading a PV Team and performing the role of an LSO;
  • Minimum of 8 years' experience in the pharmaceutical industry, with at least 3 years' experience in a position of responsibility within Pharmacovigilance;
  • Team leadership and people management experience are required;
  • Fluent communication skills in English and Portuguese (Spanish is a plus).
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