Pharmacovigilance Sepcialist

Who we are?

Grand Medical Pty Ltd. is an Australian biotechnology company with a mission to be a premium integrated medical service platform and medicinal products R&D centre in Australia. Grand Medical is a subsidiary of Grand Pharma (China) Co. Ltd (“Grand Pharma”) – a world-leading pharmaceutical company, headquartered in China, with global business engagement and R&D layout covering globally. Grand Pharma has been publicly listed on Hong Kong Stock Exchange since 2008 (Stock Code: HK00512).

Grand Medical has been proactively collaborating with the Australian leading research institutes, and pharmaceutical R&D organisations in the development of medical products to address some of the most challenging diseases to expand the company’s product portfolio.

Grand Medical is also deepening the collaborations with our R&D partners in Australia for jointly establishing an R&D platform to independently conduct specified research projects. 

Grand Medical is also a sponsor for ARTG registered prescription medicine and will practice its full sponsor responsibility and obligation for the registered products.

We are offering a new and exciting opportunity for a Pharmacovigilance (PV) Specialist to join in our team. This position is based in Brisbane and reported to the PV head at headquarter, China.

Responsibilities:

The accountabilities of the PV specialist include the oversight of, and influence on, the structure, performance, and maintenance of Biopharma’s PV system. This includes:

• To perform as the local pharmacovigilance contact person in Australia for GrandMedical
• Maintenance of Biopharma’s global PV System under the support of the headquarter.
• Maintenance of the written agreements with other companies (including business partners, vendors, and other third parties) are in place regarding safety and overseeing their work
• Processing safety reports and reporting to competent authorities accordingly.
• Continuing evaluation and appropriate handling and communication of the benefit-risk analyses of Medicinal Products at Biopharma
• Other PV tasks that are assigned by the headquarter.

Education

• Tertiary qualifications in Medical, Medical Science, pharmacy, or other related healthcare disciplines

About You

• Experienced in pharmacovigilance and relevant legislation in Australia for more than 1 year. 
• Medically qualified, or if not, have ready access to a medically qualified person for any clinical assessments necessary. 
• Knowledge of national and international regulations for PV 
• Experience in identifying critical situations/emerging safety issues from a drug safety point of view
• Good understanding of signal detection and risk management

You must have the right to live and work in this location to be considered for this job.