Healthcare Medication Regulatory Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeePatient Full time $90,000 - $121,000
Job Title:

Specialist Patient Safety

Job Description:

At Sandoz, we are committed to ensuring the quality use of medicines for millions of patients worldwide. We believe that new insights and perspectives can be found at the intersection of medical science and digital innovation. Our diverse and inclusive environment inspires new ways of working, and our culture is underpinned by integrity, curiosity, and flexibility.

We are seeking a highly skilled Patient Safety Specialist to support the management of patient safety operational processes at Country Organization level. This role will involve ensuring compliance with Sandoz global/local procedures, national and international regulations, standards, and guidelines for vigilance of both marketed and investigational products from Sandoz Group.

The successful candidate will have experience as a Patient Safety specialist, health care sciences professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience. They will possess knowledge of national and international regulations and terminology for pharmacovigilance, pharmacological and medical terminology, excellent communications, interpersonal, and negotiation skills. Quality and focus-oriented, they will also have a high level of digital literacy.

Key Responsibilities:

  • Manage the collection, processing, documentation, reporting, and follow-up of all adverse event reports for all Sandoz products from clinical trials, non-interventional studies, patient-oriented programs, literature, spontaneous reports, etc.
  • Transcribe, translate, and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
  • Manage the reporting and submission of safety reports to the Local Health Authorities (LHA) and/or clinical operations in collaboration with other Country Organization Departments.
  • Work with other local and global Patient Safety associates to ensure accurate evaluation of safety data.
  • Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups, and third-party contractors, if applicable.
  • Survey and supervise national pharmacovigilance regulations and provide updates to global Patient Safety organization.
  • Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
  • Input, review, and approval of program proposals for language, content, and establishment of vital controls on collection and reporting of adverse event information.
  • Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance, and third-party contractor, if applicable) for potential AEs resulting from medical inquiries, quality-related complaints, and other sources.

Benefits:

  • Flexible working arrangements.
  • Learning and development opportunities.

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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