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Senior Pharmacovigilance Professional

2 semanas atrás

Brasil beBeeExpert Tempo inteiro
Pharmacovigilance Expertise

We are seeking a skilled Pharmacovigilance Associate to join our team. As a key member of our organization, you will be responsible for leading the collection, evaluation, and processing of adverse event reports.

Responsibilities:
  • Collect, evaluate, and process adverse event reports in accordance with regulatory guidelines and company policies.
  • Analyze safety data, identifying trends and potential safety signals that require further investigation.
  • Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
  • Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
  • Maintain pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
  • Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
  • Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Qualifications

To succeed in this role, you will need:

  • A Bachelor's degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.
  • Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
  • Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
  • Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
  • Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
  • Commitment to maintaining confidentiality and handling sensitive patient information with discretion.
Benefits

Our organization offers a range of benefits to support your career development and well-being, including:

  • Competitive salary and bonus structure.
  • Opportunities for professional growth and advancement.
  • Comprehensive health insurance and wellness programs.
  • Flexible working arrangements and paid time off.
  • Access to cutting-edge technology and resources.
Inclusive Culture

We are committed to creating an inclusive culture where everyone feels valued and supported. Our organization celebrates diversity and promotes equal opportunities for all employees. We believe that our unique perspectives and experiences are essential to driving innovation and excellence.