Local Safety Administrator
Johnson & Johnson
Bucharest, Romania
11 zile în urmă

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.co m for more information. Janssen, part of Johnson & Johnson Family of Companies is now looking for Local Safety Administrator : LOCAL SAFETY ADMINISTRATOR Location : Bucharest Full time permanent contract Role Overview The Local Safety Administrator provides support to the Local Safety Officer (LSO) in all administrative aspects of Safety Management and Reporting at the local operating company (LOC) level. Key responsibilities :

  • To be compliant with Pharmacovigilance legislation and Company procedures
  • Support the collection of spontaneous AEs from the marketplace, local Health Authorities and, serious adverse events from clinical trials;
  • be part of local safety assessment team.

  • Conduct administrative review of local individual cases as requested by LSO
  • Coordinate translation of local source documents as required
  • Maintain up to date local tracking system to track reporting to Competent Authorities, connected to individual and aggregate reports, clinical trials, medical and marketing local / regional projects
  • Responsible for the filing and maintenance of all reports documentation, including original source documentation
  • Support the implementation of compliance standards and collection of compliance metrics as required
  • To be connected with internal stakeholders and to collect relevant safety data
  • Our Requirements :

  • Good verbal and written communication skills with a knowledge of medical terminology
  • Strong organisational skills, attention to detail and accuracy are important
  • Computer literate and competent in Microsoft Office applications, technology, resources and contacts within and outside J&J to support activities
  • Able to build familiarity with resources and contacts within the company to support the group and its objectives
  • Acquires knowledge of departmental and company policies and procedures
  • Proven ability to manage projects as assigned and work unsupervised
  • Good interpersonal and communication skills
  • If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English via MyCareerOpportunities.

    net, EmployeeReferrals.jnj.com or via careers.jnj.com

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