Pharmacovigilance Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil beBeePharmacovigilance Tempo inteiro R$120.000 - R$150.000

Job Opportunity

As a Pharmacovigilance Analyst, you will be responsible for ensuring the quality management of all procedures and implementation of audit findings in Latin America. This role requires strong technical expertise and excellent communication skills to ensure compliance with local and international regulations.

Key Responsibilities:

  1. Ensure compliance with local and international regulations through effective communication with regulatory bodies.
  2. Respond promptly to health authority requests regarding safety information, maintaining accurate and complete communication.
  3. Manage post-marketing surveillance activities by reviewing and submitting adverse event reports.
  4. Develop, review, and update pharmacovigilance procedures specific to Latin America, aligning with current regulations and good practice guidelines.
  5. Conduct pharmacovigilance training for employees across Brazil and Latin America.
  6. Prepare and review periodic pharmacovigilance reports, including safety monitoring and risk minimization plans.
  7. Report adverse drug reactions to Latin American health authorities via electronic systems.
  8. Maintain pharmacovigilance and customer service documentation in accordance with good practices.
  9. Participate in meetings with regulatory bodies and stakeholders to align market actions and anticipate regulatory needs.

Required Skills:

  • Excellent verbal and written communication skills.
  • Strong relationship management, problem-solving, and negotiation skills.
  • Fluent in English and Spanish.
  • 5-7 years of experience in pharmacovigilance.
  • Knowledge of pharmacovigilance legislation, technovigilance, NOTIVISA, and CVS.

Education:

  • Professional healthcare education with pharmacovigilance experience.


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