Safety Reporting Specialist

hace 6 días


Xico, México Engineeringuk A tiempo completo

About Engineeringuk

At Engineeringuk, we're a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. Our diverse and dynamic team fosters an inclusive environment that rewards high performance and nurtures talent.

Job Overview

We are currently seeking a Safety Reporting Specialist to join our team. As a Safety Reporting Specialist at Engineeringuk, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization's pharmacovigilance reporting processes and maintain compliance with regulatory standards.

Responsibilities

  • Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
  • Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
  • Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
  • Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
  • Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
  • Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
  • Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.
  • Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting.

Requirements

  • Bachelor's degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.
  • 2-3 years extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
  • Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
  • Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
  • Advanced English is a must.
  • Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
  • Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
  • Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

What We Offer

  • A competitive salary range of $90,000 - $110,000 per annum, depending on experience.
  • An estimated salary of around $100,000 per annum, considering the hybrid work schedule and benefits package.
  • A range of additional benefits, including various annual leave entitlements, health insurance offerings, retirement planning, and global employee assistance programs.


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