Manufacturing Site Pharmacovigilance Representative (APAC sites)

Location:Broadmeadows, Parkville
Job Type:Full Time

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Manufacturing Site Pharmacovigilance Representative´s main objective is the liaison between Global Clinical Safety and Pharmacovigilance and the Product Quality Management functions at the CSLB and Ruide manufacturing sites (Wuhan) and Broadmeadows (Australia). Together with the Global MSPR group, the position holder will also support Marburg, Bern, Lengnau and Kankakee sites. The position will be located in the Melbourne area.

The Opportunity:

In this newly created role you will report to the Global Manufacturing Site Pharmacovigilance Representative and you will collaborate closely with the Global Team to ensure cooperation with Global Quality and the manufacturing sites QA. You will help create and further develop the interface to the manufacturers QA. You will prepare assessments on a high scientific level and in close cooperation with relevant stakeholders.

In this role you will be highly visible on multiple management levels. You will communicate actively and initiatively on a high scientific as well on a cultivated interpersonal level. The role will require travelling in coordination with the Global MSPR.

To be successful in this position you will possess:

  • University graduate in life-sciences (pharmacy or pharmacology or biology or human / veterinary medicine)

  • Technical knowledge of the PV and quality relevant regulatory framework and good knowledge of international regulations and standards (such as GVP, GMP)

  • Excellent written and verbal communication skills in English.

  • Strong relationship builder and communicator at various levels of the business.

  • Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive.

  • Able to work effectively and collaboratively across site functions and the GCSP organization.

  • High ethical standards as well as personal credibility, the ability to gain trust at the senior executive level.

  • Willing to learn the principles of internal audits and authority inspections.

  • Fluency in Mandarin highly desirable

  • Good team player and networker with excellent interpersonal and communication skills.

The Company:

CSL Limited is a company that fosters a work culture emphasising Superior Performance, Innovation, Integrity, Collaboration and Customer Focus with a commitment to support, train and grow its people. As a genuine leader in the biopharmaceutical industry, CSL is a multinational ASX Listed Company that is actively growing its Australian based manufacturing operations to support global growth. CSL develops, manufactures and markets products to treat and prevent serious human medical conditions and is globally one of the largest manufacturers of plasma-derived therapies.

To Apply:

Applications must address the selection criteria above and include a current CV and covering letter.

Applications close Sunday, 9th of December, 2019

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability

University graduate (Diploma/MA/MS, PhD) in life-sciences, e.g. pharmacy or pharmacology or biology or human / veterinary medicine

Technical knowledge of the PV and quality relevant regulatory framework and good knowledge of international regulations and standards (such as GVP, GMP)

  • Knowledge of local and also global CSL business processes and governance structures.
  • Excellent written and verbal communication skills in English.
  • Knowledge of CSL product profiles.
  • Strong relationship builder and communicator at various levels of the business.
  • Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive.
  • Able to work effectively and collaboratively across site functions and the GCSP organization.
  • Strong organizational skills.
  • High ethical standards as well as personal credibility, the ability to gain trust at the senior executive level.
  • Willing to learn the principles of internal audits and authority inspections.
  • Good team player and networker with excellent interpersonal and communication skills.