Medical Safety Specialist

6 hours ago

Brisbane, Queensland, Australia 4C Recruitment Solutions Full time

**Job Summary:**

We are seeking a highly skilled Medical Safety Specialist to join our expanding client in the pharmaceutical industry. As a key member of the pharmacovigilance team, you will be responsible for ensuring compliance with regulatory requirements and contractual obligations.

About the Role:

  • Administration and reporting of Individual Case Safety Reports (ICSRs) to facilitate prompt resolution and minimize risk.
  • Regulatory submission of individual and aggregate safety reports to maintain up-to-date records and ensure timely compliance.
  • Monthly reconciliations and quality control checks to guarantee data accuracy and integrity.
  • Coordination of pharmacovigilance training for employees and maintenance of employee training records to foster a culture of continuous learning.
  • Monitoring compliance with regulatory requirements, PVA obligations, and procedures to identify areas for improvement.
  • Providing support to the PV Manager during audits and inspections, as well as preparing and implementing corrective and preventative actions as necessary.
  • Documentation of medical information inquiries concerning sponsored products to ensure accurate and efficient resolution.

Requirements:

  • A minimum of [insert estimated salary, e.g., $80,000] per annum salary, commensurate with experience.
  • Pharmacovigilance experience is highly desirable, although not essential.
  • Tertiary qualification in Life Sciences or a related field is required.
  • High attention to detail, organizational, and time management skills to prioritize tasks effectively.
  • Ability to work efficiently and manage large workloads while maintaining accuracy and productivity.
  • Confident communication skills with excellent verbal and written communication abilities.
  • Presentation experience and proficiency in MS Teams and MS Office are advantageous.
  • Capacity to work collaboratively and autonomously in a fast-paced environment.

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