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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Jr Manager -L ATAM Regulatory Affairs and Pharmacovigilance

Regulatory Affairs and Pharmacovigilance Jr Manager for LATAM and Brazil
Required Skills & Background
  • Oversee projects assigned to LATAM Regulatory Affairs and Pharmacovigilance Team.
  • Represent the company in regulatory affairs, pharmacovigilance and materiovigilance matters with pharmaceutical associations and the Health Authority in LATAM and Brazil.
  • Provide Regulatory Intelligence and Strategy input to the all business areas
  • Become the Pharmacist in charge of Pharmacovigilance and Materiovigilance matters/requests from the Health Authority in Brazil.
  • Align strategically in the local, regional and global level with key corporate areas in order to ensure regulatory submission plan.
  • Ensure regulatory and pharmacovigilance compliance for all projects in LATAM and Brazil.
  • Provide coaching and training of the team for personnel development.
  • Manage and plan local budget of the area.
  • Coordinate regulatory, pharmacovigilance and materiovigilance competencies in Brazil and Latin America countries.
  • Identify major stakeholders for regulatory, pharmacovigilance and materiovigilance issues, being the interface between corporate offices in France and Brazil and Latin America areas.
  • Assure the maintenance of Marketing Authorizations in all countries in Latin America.
  • Reinforce cooperation between the subsidiaries and corporate Pharmacovigilance & Regulatory Affairs.
  • Coordinate regulatory technological and competitive intelligence in each of the countries concerned and write technical and scientific briefing notes.
  • Assure the training and development of pharmacovigilance team whenever requested by the commercial and marketing areas according to the subsidiaries' need, in the company or external visits.

 

 

 

Education, background required for the job
  • Bachelor’s degree in Pharmacy or Biology, MBA desirable.
  • Minimum of 10 years of regulatory affairs and pharmacovigilance experience in Pharmaceutical or Medical Devices companies.
  • Project management skills and solid experience on regulatory and pharmacovigilance requirements.
  • Adapted to work in matrix reporting environment
  • Leadership and great communication skills
  • Ability to summarize and interpret regulations, time management and presentation skills.
  • Self-motivated to work in a multicultural environment (international mentality).
  • Fluent in English, Portuguese and Spanish.
  • Availability to travel when needed.