With operations in 35+ nations and ~ 20,000 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 at http://www.cslbehring.com 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 at http://www.cslplasma.com/careers , 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!
Reporting to the Medical Affairs Director, the Senior Manager PV and MI will have unique responsibilities as a regional safety officer and provide medical information oversight for CSL Behring ANZ.
This will be an autonomous role where you will be responsible with liaising and providing feedback and guidance to the Medical Director and Commercial Operations teams around PV, whilst acting as an important conduit to the global safety team. You will also manage 3rd parties that have been contracted to provide medical information to the organisation.
**In this role you will:**
+ Find appropriate, innovative solutions to support commercial operations with fit for purpose processes for pharmacovigilance
+ Understand the regulatory environment and implement change and efficiencies to process that will drive the PV function
+ Interface with commercial brand teams to provide expertise and feedback where data is collected with potential safety implications
+ Work with the global safety team and regional QPPV to develop new process, execute changes through the business.
+ Determine suitability of 3rd party organisations, set up agreements, conduct due diligence and ongoing compliance checks
+ Conduct training of staff (customer service, marketing, medical etc) on what their responsibilities are on how to manage pharmacovigilance data
+ Support the global safety organistion by maintaining the pharmacovigilance system master file and implement local procedures to fit the ANZ affiliate
+ Have responsibility in delivery of the Medical Information 3rd party contract and continually review process including reporting to KPI’s and drive change.
**To be suitable for this opportunity, you will have:**
+ Advanced degree in science/medicine (MD, PhD, PharmD)
+ 9+ years’ pharmaceutical/ biotherapeutics industry experience
+ Thorough knowledge of products; experience conducting clinical trial programs desirable
+ Prior experience managing medical science liaison (MSL) team
+ Have proven experience in a pharmacovigilance and / or regulatory experience in a Life Science organisation
+ Strong knowledge of the regulatory framework for pharmacovigilance in Australia and New Zealand and knowledge of GVP
+ Experience in overseeing and managing compliance with 3rd party pharmacovigilance providers is highly regarded
+ An ability to influence and communicate with marketing and medical teams and provide them with mechanisms that fulfil our obligations
+ An ability to lead and drive process change
**Apply now to for a unique role with career development opportunities supporting the ANZ affiliate!** Please include a cover letter and resume in the one document.
Worker Sub Type:
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement