Pharmacovigilance Expert with Regulatory Compliance

hace 4 semanas

Xico, México Icon Plc A tiempo completo
About ICON Plc

At ICON Plc, we pride ourselves on being a world-leading healthcare intelligence and clinical research organization. Our diverse and dynamic team is dedicated to fostering an inclusive environment that drives innovation and excellence.

Senior Pharmacovigilance Associate Role Overview

We are seeking a highly skilled Senior Pharmacovigilance Associate to join our team in Mexico City. This hybrid role offers the perfect blend of work and personal life balance. As a Senior Pharmacovigilance Associate at ICON Plc, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities.

Job Description

Main Responsibilities:

  • Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
  • Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
  • Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
  • Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
  • Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
  • Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
  • Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Requirements and Qualifications

To be successful in this role, you will need:

  • 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.
  • Advanced English level and 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.
What We Offer

As a Senior Pharmacovigilance Associate at ICON Plc, you can expect:

  • A competitive salary: $120,000 - $180,000 per year, depending on your level of experience and qualifications.
  • An attractive benefits package, including various annual leave entitlements, health insurance offerings, retirement planning options, and more.
  • The opportunity to work with a global team of experts in the healthcare industry.
  • Professional development opportunities to enhance your skills and career growth.

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