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Commercial Eyes Recruiting: Pharmacovigilance / Drug Safety Professional

Recruiting: Regulatory Services Professional

Commercial Eyes has fabulous new projects coming on line so we are looking for the right people to join our Pharmacovigilance Team.  Working in Commercial Eyes, a leading pharmaceutical consultancy, will give you a breadth of experience across medicines (pharma, OTC), medical devices, and healthcare consumer goods as well as a range of global leading companies. 

 

The Role….

The Pharmacovigilance team are responsible for the day-to-day delivery of pharmacovigilance and safety related projects and services for our clients.  Services, include processing safety information received by, or requiring action on behalf of clients.  Projects include patient safety, support and monitoring programs. All tasks are to be undertaken according to regulatory, Commercial Eyes Pty Ltd and client procedures and Protocols. Responsibilites include;

  • Work within the systems and processes designed to meet Good Pharmacovigilance (GPV) practice.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.
  • Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.
  • Process & report safety data as per SOP’s 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 tracks agreed KPI’s in order to meet project deliverables.
  • Act as a subject matter expert both internally and externally.
  • Train and mentor other team members.
  • Proactively contribution to improving business processes.
  • Participate in internal and external audits.

 

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 (if you are a graduate with less than 12 months we also have some graduate roles so please contact us)
  • Good working knowledge of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand
  • Understanding of the applicable 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

 

In return…..

  • Be part of a well-known and established professional services organisation, that has a strong focus on teamwork and that recognises talent and expertise as one of its biggest assets.
  • Expand your network by working with a broad range of local and international industry leading companies developing cutting edge health technologies, across a global landscape.
  • A competitive salary and a flexible work environment, in an environment that respects life-work balance.
  • Interesting and challenging projects to grow and enhance your skills and experience.
  • Be part of a fabulpous team of PV professionals.
  • Fabulous cbd location and offices.

 

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au

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 Lorenza Ricacho Director, Medical Services for a private and confidential discussion on +61392510777.




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Commercial Eyes Recruiting: Pharmacovigilance Manager

Recruiting: Regulatory Services Professional

People and Function leader!

Commercial Eyes has a great opportunity for an experienced Pharmacovigilance professional who is ready to lead a substantial team to deliver a global pharmacovigilance service.  This role will lead the Pharmacovigilance function partnering with Medical Information and Medical Communications & Patient Engagement leaders to ensure the delivery of benchmark Medical Services for Industry leading pharmacy and medical devices companies. 

 

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

  • Post graduate qualifications in a scientific discipline such as pharmacy, pharmacology, nursing or drug development.
  • 5 years plus industry experience in a Senior Drug Safety role.
  • Experience leading a team.
  • Previous consulting experience or a strong interest in the practise of consulting.
  • Knowledge and experience with PV compliance audits.
  • Experience with prescription, listed and complementary medicines, devices and consumer goods.
  • Strong experience authoring/preparing Periodic Safety Update Reports, Periodic Benefit Risk Evaluation Reports, and Risk Management Reports (PSURs/PBRERs and RMPs) including risk management and signal detection.
  • Detailed knowledge and understanding of EU, FDA, Australian, and New Zealand regulatory requirements for safety reporting and the systems and processes needed to ensure compliance.
  • Good knowledge of key overseas regulations relating to pre and post-market drugs, device and consumer goods safety.
  • Demonstrated experience managing pharmacovigilance quality management systems.
  • Highly developed communication, organisational and problem-solving skills.

 

The rewards….

  • Be part of a well-known and established professional services organisation, that has a strong focus on teamwork and that recognises talent and expertise as one of its biggest assets.
  • Work with a broad range of local and international industry leading companies, across a global landscape, developing cutting edge health technologies.
  • A competitive salary and a flexible work environment, in an environment that respects life-work balance.
  • Interesting and challenging projects to grow and enhance your skills and experience. 
  • Fabulous cbd location and offices.

 

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au

Please contact Lorenza Ricacho on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description




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Commercial Eyes Recruiting: Health Economist

Recruiting: Health Economist

Commercial Eyes has a Unique and Exciting Opportunity for a Health Economist

This role is pivotal to enhancing our comprehensive and competitive pricing and reimbursement practice. The primary focus of the role is to provide high quality technical health economic and statistical input for a diverse range of projects including feasibility assessments, reimbursement strategy development and funding submission development (PBAC, MSAC, NBA, PLAC, PHARMAC).

Critical to this role is the ability to demonstrate pragmatism, integrity, collaboration in a team environment and confidence when liaising with clients to deliver customer-focussed outcomes according to agreed deadlines and client requirements.

 

To be successful in this role you will ideally possess:

  • Undergraduate tertiary qualifications in economics or a life sciences discipline;
  • Post-graduate qualifications in health economics, epidemiology, statistics, or health sciences;
  • A thorough understanding of statistics and health economic modelling methodologies;
  • Advanced skills with modelling software, in particular MS Excel;
  • Excellent numerical and analytical skills demonstrated in an appropriate professional setting (industry, academic, government);
  • Attention to detail and ability to produce work of consistently high quality;
  • A strong understanding of the Australian health care market and funding mechanisms;
  • A keen interest in the practice of consulting.

 

The rewards…

Our consultants draw on significant accrued experience and know-how gained from the exposure that comes with being part of a highly regarded consultancy that offers a full suite of commercialisation services. The Market Access team consists of industry specialists with a practical and thorough understanding of the challenges to market access in Australia and New Zealand, and appreciate the importance of a holistic approach backed by sound technical capability.

 

Please contact Tenille Manuele on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description.




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Commercial Eyes Recruiting: Market Access Professional

Regulatory Services Manager

Commercial Eyes has a great opportunity for a Market Access Professional

to join our established Market Access team in the capacity of Senior Consultant or Consultant. These roles are pivotal to enhancing our comprehensive and competitive pricing and reimbursement practice through the provision of technically sound strategic advice, feasibility assessment, health economics activities and funding submission development.

 

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

  • Undergraduate tertiary qualifications in economics or a life sciences discipline and/or;
  • Post-graduate qualifications in health economics, epidemiology, statistics, or health sciences;
  • Commercial life sciences experience in health outcomes, market access, health economics or a related discipline;
  • Knowledge of the Australian and New Zealand healthcare landscapes, particularly the reimbursement environment and processes (PBAC, MSAC, PLAC, NBA and/or PHARMAC);
  • Excellent verbal reasoning, written communication and project management skills;
  • Previous consultancy experience or a keen interest in the practice of consulting;
  • Experience in negotiating with key Government stakeholders and/or pricing experience will be highly regarded.

 

Critical to these roles is the ability to demonstrate pragmatism, integrity, collaboration in a team environment and confidence when liaising with clients to deliver customer-focussed outcomes according to agreed deadlines and client requirements.

 

The rewards…

Our consultants draw on significant accrued experience and know-how gained from the exposure that comes with being part of a highly regarded consultancy that offers a full suite of commercialisation services. The Market Access team consists of industry specialists with a practical and thorough understanding of the challenges to market access in Australia and New Zealand, and appreciate the importance of a holistic approach backed by sound technical capability.

 

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au.

Please contact Tenille Manuele on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description.




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Commercial Eyes Recruiting: Medical Information Professional

Recruiting: Health Economist

Commercial Eyes has a great opportunity for a Medical Information professional

to join our Medical Information team on a full-time basis. The ideal candidate will have prior experience in the provision of scientific information and the report of spontaneous adverse events and product complaints in a pharmaceutical company or hospital setting.

 

To be successful in this role, you will have…

  • Excellent verbal reasoning and written communication skills
  • Highly developed time management, problem solving and project management skills
  • Proficient in building productive relationships and networks
  • A keen interest in the practice of consulting

 

Key responsibilities include:

  • Handle and disseminate technical and scientific information in a timely manner in response to enquiries received from healthcare professionals and patients, as well as internal business units, regarding relevant client’s products
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database
  • Respond to customer queries using various research strategies, including performing literature reviews
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures
  • Abide by relevant client requirements and country regulations in respect to managing customer complaints, adverse events and handling of enquiries
  • Adhere to company and regulatory requirements, as well as voluntary codes of practice

 

In Return…

This role is a rewarding one that offers all the traditional benefits of employment, such as competitive salary, a supportive & respectful culture and a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

 

Applications from recruitment agencies will not be considered.

 

To apply for this job, please submit your CV and cover letter to recruitment@commercialeyes.com.au

Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad




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Transition to eCTD is gaining momentum in Australia

eCTD Submissions

At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for enhancing evaluation workflows and encouraged industry to make the transition to eCTD.

The TGA have published an updated eCTD AU module 1 and regional information specification and guidance for use (version 3.1).

https://www.tga.gov.au/publication/ectd-au-module-1-and-regional-information

The updated specification will be effective from 1 January 2018 and become mandatory from 30 June 2018. A number of new features have been incorporated into the AU specifications to support the Medicine and Medical Device Review (MMDR) recommendations, facilitate document lifecycle management and enhance the overall quality of dossiers.

The key features introduced into the updated specification include:

  • New sequence types to cater for provisional registrations and future post-approval notifications
  • Inclusion of new subfolders within Module 1.3 Medicine Information and Labelling to distinguish “approved” documents and facilitate appropriate life cycle management through the use of the “replace” operation.
  • Additional validation criteria and updated best practice guidance regarding the use of bookmarks and hyperlinks, which now raises:
    • Documents that contain bookmarks and hyperlinks with web or email destinations as a “warning”
    • Documents longer than 10 pages which do not contain bookmarks as “Information”
  • Updates to the eCTD envelope to facilitate future automation of TGA validation of dossiers
  • Structural changes to the eCTD envelope to allow the future possibility for multiple changes for a single product (“work grouping”) or the same changes for multiple products (“work sharing”)

An updated AU NeeS specification and guidance for use version 2.0 has also been published and follows the same implementation timelines as the updated eCTD specification.

https://www.tga.gov.au/publication/nees-au-module-1-and-regional-information

The key new requirement for applications in NeeS format is the introduction of a “NeeS envelope form” to assist the manual creation of an envelope.xml file. This NeeS envelope file is similar to the eCTD envelope and contains background information, such as the sponsor and application type, for each sequence/application. While completion of this form appears user friendly and not particularly onerous, this additional requirement provides further incentive for Sponsors to transition to eCTD!

 

To discuss how Commercial Eyes can assist you with all your eCTD and NeeS needs call our Regulatory Services team on +61 3 9251 0777.




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Commercial Eyes Recruiting: Medical Information Associate

Regulatory Services Manager

Commercial Eyes has a great opportunity for a Medical Information Professional

to join our Medical Information team on a fixed term 6-month contract. The ideal candidate will have prior experience in the provision of scientific information and the report of spontaneous adverse events and product complaints in a pharmaceutical company or hospital setting.

 

To be successful in this role, you will have…

  • Excellent verbal reasoning and written communication skills.
  • Highly developed time management, problem solving and project management skills.
  • Proficient in building productive relationships and networks.
  • A keen interest in the practice of consulting.

 

Key responsibilities include:

  • Handle and disseminate technical and scientific information in a timely manner in response to enquiries received from healthcare professionals and patients, as well as internal business units, regarding relevant client’s products
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database
  • Respond to customer queries using various research strategies, including performing literature reviews
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures
  • Abide by relevant client requirements and country regulations in respect to managing customer complaints, adverse events and handling of enquiries
  • Adhere to company and regulatory requirements, as well as voluntary codes of practice

 

In return….

This role is a rewarding one that offers all the traditional benefits of employment, such as competitive salary, a supportive & respectful culture and a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement. 

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise. 

 

For more information about this role, please visit our Seek ad.

Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad. 




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TGA Inspections are Coming – Is your Company Ready?

TGA Inspections

The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia.  Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies.  The selection process by the TGA considered a) the type of company and b) the products of these companies.  The TGA tried to include a comprehensive group of organisations (including large multinationals, generics companies, complementary/herbal medicine companies, smaller biotechnology companies, and Australian owned and based companies) with the view that the inspections would encompass an extensive portfolio of medicines (registered, listed, OTC, complementary, vaccines, innovative, generic, topical, oral, nasal, IV, those with and without RMPs/PSURs).

The inspection process itself was similar to those inspections conducted by other Competent Authorities such as the MHRA, in that the process was divided into pre-inspection phase, inspection phase, and post-inspection phase.

  1. Pre-Inspection – 1 month prior to inspections, a draft agenda and initial document request were sent to the companies.
  2. Inspection – consisted of opening meeting, interview sessions (to gain understanding of PV processes), document requests (to allow the inspectors to verify statements in the interviews), review of documents, and a closing meeting (verbal overview of findings)
  3. Post-Inspection – 4 weeks following the receipt of the last document sent by each company to the TGA, a formal inspection report was provided to the company. The companies were given 4 weeks to respond to the findings (using a CAPA plan to record the findings, then carry out any necessary actions), the proposed CAPAs were assessed by the inspectors (changes and/or additions negotiated between the TGA and company), and the inspection process was deemed to be closed.

The TGA Inspectors considered the following during their inspections: ADR collection and processing, processes for ongoing monitoring of safety, PSUR production and co-ordination, maintenance of RSI, the Australian RPPV, and relevant Australian PV legislation and guidelines.

The formal inspection report graded the deficiencies as either

  • Critical – deficiencies in the PV practice or processes of the company that already have or may significantly and adversely affect the safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.
  • Major – deficiencies in the PV practice or processes of the company that could potentially adversely affect the safety or well-being of patients or that could pose a potential risk to public health or that represents a significant violation of applicable legislation and guidelines.
  • Other – a deficiency that cannot be classified as either critical or major, but indicates a departure from good pharmacovigilance practice. These deficiencies are not deemed to be expected to adversely affect the safety or well-being of patients.  It may be a deficiency which has been judged as minor, or because there is insufficient information to classify it as major or critical.

The pilot program demonstrated that the majority of findings were in the following areas:

  • Australian RPPV roles and responsibilities,
  • Deficiencies in procedural documentation,
  • Ongoing monitoring processes,
  • Submission of PSURs (deviation from the PSUR submission schedule),
  • Significant safety issues communication (late communication to the TGA),
  • Maintenance of RSI (delays in updating Australian product information, delays in updating CMI documents), and
  • AE case collection and processing (late/non-submission to the TGA, non-conservative seriousness assessments, lack of due diligence in identification of AEs and special situation reports, deficiencies in PV contracts and training of vendors)

Since the purpose of the pilot program was for the TGA to characterise how they consider is the best way to progress with inspections in the future.  The volunteering companies were asked to fill out a questionnaire, and responses have been useful and given the TGA further points to consider.  Points such as challenges with time zone differences were raised.

The TGA are in the process of determining whether a national PV inspection program is feasible, and the industry should hear more information via a consultative process shortly.

 

Please contact our expert Pharmacovigilance team on +61 3 9251 0777 for assistance in making sure you are ready for those inspections

This article was written by Beverley Worrall, from our Pharmacovigilance team




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What is food for special medical purposes (FSMP)?

Food for Special Medical Purposes

With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can patients access them? Is it classified as therapeutic goods? Who is the regulator of such products?

As per Standard 2.9.5 – Food for special medical purposes under Food Standards Australia New Zealand Act 1991 (Cth), FSMP means food that is:

  1. Specially formulated for the dietary management of individuals:
    1. By way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food; and
    2. Whose dietary management cannot be completely achieved without the use of the food; and
  2. Intended to be used under medical supervision; and
  3. Represented as being:
    1. A food for special medical purposes; or
    2. For the dietary management of a disease, disorder or medical condition.

In Short, FSMP may be used to help people suffering certain diseases, medical conditions or disorders and cannot meet the nutritional requirements via normal diet.

Even though they are food, consumers, cannot purchase them from local supermarkets. FSMP can only be provided via health care professionals, such as a medical practitioner or dietitian or pharmacists.

However, they are not considered therapeutic goods. The line between a medicine and therapeutic food has become even greyer over the past few years. TGA has developed an online tool – Food-Medicine Interface Guidance Tool – and encourages customers to familiarise themselves with the basics of food and medicine and regulation. Manufacturers and sponsors can also use the Tool to work out which regulatory regime would apply to their products.

Unlike therapeutic goods regulated by the TGA, FSMP are regulated by Food Standards Australia New Zealand (FSANZ), who developed the Food Standards Code. Standard 2.9.5 of the Food Standards Code regulates the composition, labelling and sale of food for special medical purposes. It limits FSMP to make any therapeutic claims, for example, FSMP cannot make a claim in relation to the prevention of the disease.

Because FSMP is so similar to a medicine, it may cause undesired effects as well. However, which regulatory authority should we report to? Under the mandatory reporting obligations section of the Australian Competition and Consumer Commission (ACCC) guidelines: “Individual suppliers are responsible for reporting incidents where consumer goods have been associated with a death or serious injury or illness of any person.” The manufacturers of the FSMP may wish to be conservative and report such cases to ACCC.

 

Our Medical Services team has extensive experience in Food for Special Medical Purposes. Call us on +613 9251 0777 to discuss how we can assist.

This article was written by Wenna Zhang, from our Medical Services team.




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Stressed? Well your products should be!

Forced Degradation Studies

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier.

Assay results of around 100% are certainly ideal, but if your test method cannot distinguish the active ingredient from any impurities formed through degradation, then how can you be sure your product will remain safe and efficacious throughout its shelf life?

Forced degradation studies, also known as ‘stress testing’ studies, are used to demonstrate that the assay and impurity test methods are sensitive to the full range of potential degradation products that could form over the shelf-life of a drug product or drug substance. Regulatory authorities will expect to see this data in Module 3 of a registration dossier; however, it is important that the studies are performed correctly.

So how much stress?

Detailed instructions on how to perform stress testing are not readily available in published regulatory guidance documents. This is because there is no “one size fits all” when it comes to stress testing. What may be adequate for one product may be too extreme for another. Instead, stress testing studies should be designed considering the nature of the drug substance and drug product, along with some common sense.

Companies often apply conditions that are either too drastic, resulting in irrelevant degradation, or sometimes the conditions applied are not harsh enough and result in little or no significant degradation being observed. The ideal result under each of the five stress conditions (acid, base, oxidising, heat, light) is that the main compound is degraded by around 5-15% (ideally 10%). The conditions applied should also allow for some predictability of degradation pathways. Chromatographic conditions should ensure that degradants can be separated (as much as possible) and that they don’t interfere with measurement of the main compound or previously known impurities and degradants.

What about mass balance?

Another important measure of an acceptable stability-indicating test method is its ability to account for all the components produced under stressed conditions and over the ordinary shelf-life of the product. Ideally, the amount of decrease in the main active component has a directly corresponding increase in the amount of all the measured impurities and degradants. Where this is not the case, a few factors will need to be considered to ensure that mass balance can be achieved (or differences understood) such as improvements to the test method(s), changes to the stress conditions or possible degradation pathways which may hinder the detection or measurement of specific compounds.

Stress-testing is an important validation consideration and should be conducted very early in the development or implementation of new test methods rather than leaving it until regulatory authorities raise questions on the results.

 

Want to know more?

For assistance in reviewing or designing your forced degradation studies, please contact our expert Regulatory Services team on +61 3 9251 0777

This article was written by Tim Dow and Colleen Turnbull, from our Regulatory Services team




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