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 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
- 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 firstname.lastname@example.org.
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.