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PHARMAC prepares to take over the procurement of medical devices

Access to medical devices in New Zealand is changing

 

The Therapeutic Products Bill will be published shortly, resulting in PHARMAC assuming responsibility for the procurement and funding of medical devices in addition to their current brief of medicines. This is due to the establishment of a joint regulatory scheme to incorporate all therapeutic products (medicines including cell and tissue products and medical devices). This Bill replaces the Medicines Act that has been in place since 1981.

 

It is widely acknowledged that PHARMAC has implemented policies that have resulted in the procurement of the lowest priced drugs in the OECD. However, PHARMAC has also implemented policies have resulted in significant delay in access to new medicines, primarily due to working with a fixed yearly budget.

 

Professional medical societies agree that the Medicines Act 1981 is outdated and no longer fit for purpose but have expressed concern regarding the potential change in patients’ access to medical devices.

 

Considering the potential impact of disruptions to the supply chain and reduced availability of medical device products, it is critical to have a practical and thorough understanding of the challenges to market access in New Zealand to successfully navigate the increasingly complex PHARMAC reimbursement system. 

 

The Commercial Eyes Market Access team is highly experienced in developing reimbursement strategy and funding applications for consideration by PHARMAC. For assistance in navigating the PHARMAC reimbursement and pricing landscape, please contact Tenille Manuele (Director, Market Access & Pricing): [email protected]

Posted in Life Sciences Industry, Market Access, Medical Device | Tagged , , , , , , | Comments Off on PHARMAC prepares to take over the procurement of medical devices

Commercial Eyes Recruiting: Drug Safety Associate

Drug Safety

Accelerate your career in Pharmacovigilance join our growing team.

The role…

This role is a unique opportunity to take your career to the next level, through exposure to pharmacovigilance projects across a range of companies and products. Join an experienced and growing team, delivering drug safety and risk management services on behalf of a range of clients (prescription, OTC, medical device, consumer goods, local & global). Duties include;

  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.
  • Evaluate adverse events and follow up reports received from various channels and assesses seriousness based on criteria.
  • Work with a team to ensure delivery of client project outcomes and deliverables ensuring compliance.
  • Work within the systems and processes designed to meet Good Pharmacovigilance (GPV) practice.
  • Process and report safety data as per SOPs and client instructions in order to maintain client and regulatory compliance.
  • Maintain the integrity of client safety data registered into GxP databases and associated paper-based systems.
  • Prepare project reports and track agreed Key Performance Indictors (KPIs) in order to meet project deliverables.

 

To be successful in this role, you will ideally possess…

  • Health Science degree, or equivalent.
  • At least 12 months’ experience in a drug safety or equivalent role in a highly regulated industry e.g. pharmaceutical or devices.
  • Good working knowledge of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand.
  • Understanding of the applicable MHRA and EU requirements.
  • Highly developed service, communication, organisational and problem-solving skills.
  • High level of attention to detail and computer literacy with experience in safety databases.
  • Practical experience in SOP writing and document management.

The rewards…

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health
  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

To apply, please submit your CV and cover letter to [email protected]

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

Please note to apply for this role you must be a permanent resident or citizen of Australia.

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Human Resources or for a private and confidential discussion on +61 3 9251 0777.

Posted in Commercial Eyes, Medical Services, Pharmacovigilance, Recruiting | Tagged , , , , | Comments Off on Commercial Eyes Recruiting: Drug Safety Associate

Commercial Eyes Recruiting: Administration Assistant

If you love being organised, meeting deadlines, and supporting a team to do the same..keep reading!

 

The role…

You will be a pivotal part of the team supporting regulatory consultants and associates to provide a superior client experience and to deliver optimal project outcomes.  Duties include;

  • Support team to prepare documents and presentations.
  • Co-ordinate delivery of documents to TGA and Medsafe.
  • Track and store projects and client communications.
  • Quality Management System activities such as document preparation and communication, training materials and records.
  • Project related administrative support.
  • Ad-hoc administrative tasks.

 

To be successful in this role, you will ideally possess…

  • 5+ years experience in administration support
  • Excellent systems and administrative skills
  • Strong attention to detail, timeliness and problem-solving
  • Strong computer skills
  • Excellent oral and written communication
  • Well-presented professional manner
  • Proven customer service orientation
  • A flexible and a positive demeanor

The rewards…

  • Work for a company consistently delivering excellence
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Deliver work that makes a difference to people’s lives through health
  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment

 

To apply, please submit your CV and cover letter to [email protected]

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

Please note to apply for this role you must be a permanent resident or citizen of Australia.

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Human Resources or for a private and confidential discussion on +61392510777.

Posted in Commercial Eyes, Recruiting, Regulatory Services | Tagged , , , | Comments Off on Commercial Eyes Recruiting: Administration Assistant

Commercial Eyes Recruiting: Medical Information Associate

Medical Information Associate

Accelerate your Med Info Career

 

The Role…

This role is a unique opportunity to take your career to the next level, through exposure to medical information across a range of companies and products. Join a great team, providing Med Info services on behalf of a range of clients (pharmaceutical, medical device, local & global) to enquirers including; healthcare professionals, consumers, and the client’s internal staff.

 

Duties…

  • Receive, assess and respond to medical information enquiries in a timely and compliant manner.
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database.
  • Respond to customer queries using various medical databases and research strategies, including performing literature reviews.
  • Perform literature searches using Pubmed or similar databases to answer enquiries.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures and regulations.
  • Liaise with clients to resolve enquirer questions.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

To be successful in this role, you will ideally possess…

  • Health Science degree (Pharm, BioMed, PharmSci, etc).
  • Experience in medical information (pharmacy,hospital,industry).
  • Knowledge of the principles of medical information.
  • Ability to conduct basic literature searches using Pubmed or Embase.
  • Technical writing skills.
  • Knowledge of prescription, medical device and/ or complementary medicines.
  • Knowledge of Australian regulations in medical information and drug safety reporting.
  • Highly developed verbal and written communication, organisational and problem-solving skills.

The rewards…

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and develops your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

At Commercial Eyes we believe in doing what is right.

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

Please note: to apply for this role you must be a permanent resident or citizen of Australia. Commercial Eyes does not accept applications from recruitment agencies.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information call, HR on 61 3 92510777.

Posted in Commercial Eyes, Medical Services, Recruiting | Tagged , , , | Comments Off on Commercial Eyes Recruiting: Medical Information Associate

No CE mark? No problem.

CE Mark

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia.

Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device or IVD on the ARTG. Waiting for the European CE mark to be granted often resulted in delayed entry of devices into the Australian market.

In August 2018, a change was made to the legislation that permits the TGA to accept certification from a number of other markets with similar regulatory systems.  Acceptable certification includes decisions of the United States Food and Drug Administration (US FDA), approvals and licences issued by Health Canada, pre-market approvals from Japan and Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).

The change has removed the reliance on the European notified bodies’ EC certificates, providing greater flexibility for sponsors, especially those based in North and South America.

If you’re looking at bringing a medical device to Australia the absence of a CE mark may no longer be an issue.

If you need assistance with medical devices in Australia, please contact our Regulatory Services team.

Posted in E-Health/Technology, FDA, Regulatory Services, TGA | Tagged , , , , | Comments Off on No CE mark? No problem.

Commercial Eyes Recruiting: Research Associate, Market Access

Apply your research and healthcare skills to support our growing market access team.

 

The role…

This role is part of the Market Access team and will work closely with consultants to deliver expert consulting services to clients in the key areas of pricing and reimbursement strategy, feasibility assessment, health economics, statistics, submission development, and private/public market pricing in Australia and New Zealand. Responsibilities include;

 

  • Source, collate, analyse and present various clinical, epidemiological and health economic data from multiple sources
  • Conduct and write up literature reviews
  • Interpret clinical and epidemiological studies, biostatistics and health economics data
  • Draft submissions, reports and presentations
  • Assist with the development of Market Access proposals

 

To be successful in this role, you will ideally possess…

  • Degree in health-related discipline and postgraduate qualifications in health economics, epidemiology, biotechnology, or similar.
  • Demonstrated grasp of the Australian healthcare landscape and stakeholders
  • Advanced Excel (Macros, VBA and data modelling) an advantage.
  • Highly effective research and analytical skills
  • Excellent verbal reasoning and written communication skills
  • Highly developed interpersonal and team working skills
  • Strong attention to detail and timelines
  • Ability to progress multiple projects simultaneously
  • A keen interest in the practice of consulting

 

The rewards…

At Commercial Eyes we work with and support the industry’s best.  At Commercial Eyes you will:

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

At Commercial Eyes we believe in doing what is right. At Commercial Eyes you will:

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Access workplace flexibility that fits your life and the customer’s needs
  • Join a company that is generous to the community

To apply, please submit your CV and cover letter to [email protected]

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

 

Please note to apply for this role you must be a permanent resident or citizen of Australia.

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Human Resources for a private and confidential discussion on +61 3 92510777.

Posted in Commercial Eyes, Life Sciences Industry, Market Access, Recruiting | Tagged , , , | Comments Off on Commercial Eyes Recruiting: Research Associate, Market Access

PHARMAC issues a call for funding applications for medicines for rare disorders

PHARMAC Call for Funding

Applications will be accepted until 5pm on the 5th of August 2019 and will be considered by the Rare Disorders Subcommittee at their meeting scheduled for the 24th of September 2019.

 

Eligibility criteria:

  • The medicine must have been approved by Medsafe or an approved international regulatory authority for the identified indication;
  • The disorder is a clinically defined disorder affecting an identifiable and measurable patient population with a prevalence of less than 1:50,000 in NZ;
  • The medicine is only registered for the treatment of the rare disorder, or if it is registered for other disorders (or is part of Phase 3 clinical trials for other disorders), the cumulative prevalence across all indications is still less than 1:50,000 in NZ.

 

Additionally, applications should still meet the requirements of a full funding application, addressing the Factors for Consideration, as per standard PHARMAC submissions.

 

For assistance in the preparation of an application to PHARMAC, please contact [email protected]

Posted in Life Sciences Industry, Market Access | Tagged , , | Comments Off on PHARMAC issues a call for funding applications for medicines for rare disorders

Commercial Eyes Recruiting: Contracts Administrator

Apply your contracts administration skills to this new role and establish systems and processes and then own them!

 

The role…

The Contracts Administrator is responsible for overseeing administration and compliance of client and service agreements, is part of the Business Services team and reports to the Finance Director.

 

Duties…

  • Monitor existing client and service contracts, identify and ensure compliance actions.
  • Design and implement processes to proactively monitor upcoming expiry and renewal of contracts.
  • Support the RFP process and Due Diligence Vendor questionnaires.
  • Design and implement processes to ensure contracts and client proposals adhere to our Quality Management System.
  • Maintain the Agreements Database.
  • Monthly Management Reports.

 

To be successful in this role, you will ideally possess…

  • Tertiary qualifications and/or a combination of study and work experience.
  • Demonstrated experience in contract review and administration.
  • Understanding of relevant legislation, contract administration principles, contract terms and conditions, and procurement processes.
  • Strong computer skills (MS Office and experience managing a contracts database).

 

The rewards…

  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health
  • Access workplace flexibility that fits your life and the customer’s needs
  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment

 

To apply, please submit your CV and cover letter to [email protected]

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Stephanie Gaylard, Human Resources or for a private and confidential discussion on +61392510777.

Posted in Commercial Eyes, Recruiting | Tagged , , | Comments Off on Commercial Eyes Recruiting: Contracts Administrator

IWD as HR Manager at Commercial Eyes.

I have a science degree, and I remember being a minority in the lecture theatre during my degree, I was a maths and science teacher and I remember being a minority in the staff room and having to battle the concept that girls aren’t as good at maths and science as boys. Now I am surrounded by women working in science, women leading their business units, and there is no question that girls are great at science and business.

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity. I am the HR Manager at Commercial Eyes, and I want to take the opportunity to celebrate the super smart, super successful, women that lead the business and that I get to work with.

The IWD 2019 theme is “Gender Balance”. At Commercial Eyes we work in the Life Sciences Sector, In the report by AusBiotech ‘Australia’s Life Sciences Sector Snapshot 2017’, they found that on average, women represent 50 per cent of the workforce across the entire sector; however female representation decreases as seniority levels increase’. Commercial Eyes is bucking this trend. Instead of female representation dropping as seniority levels increase, at Commercial Eyes it increases! 85% of our management team are women.

I see two key factors that I think have contributed to the strong representation of women in the Commercial Eyes management team.

When Andrew Carter, Managing Director of Commercial Eyes started the business in 2001, he worked with a talent pool of women looking for flexibility that was not at the time readily available in the industry. Incredibly talented women who wanted to balance work and family. – Flexible work practices were essential to Commercial Eyes’ early success and have gone on to become one of the companies’ core values. Today 37% of the CEPL employees work part time or casual, and many more access flexible work practices including altered core hours, and working remotely, to enable them to manage work and life.

They say, ‘success begets success’, at Commercial Eyes the question of women in leadership – is not one that needs to be pondered, because it is happening every day. Having so many women in key business leadership roles, provides role modelling and mentors for others. It’s easier to climb the mountain when you see that someone else has done it. The great thing is that as a consulting firm the female members of our management team engage with people across the sector every day, providing role modelling and inspiration beyond our doors.

It is a pleasure to be working in this environment with such great women.

Posted in Uncategorized | Comments Off on IWD as HR Manager at Commercial Eyes.

International Women’s Day Celebrations

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity.

On IWD we celebrated our amazing woman and we considered the role gender imbalance plays in Domestic Violence, and thought about what we can each do for #BalanceforBetter.

Posted in Uncategorized | Comments Off on International Women’s Day Celebrations
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