Commercial Eyes is Australia’s leading Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & New Zealand. We provide a full suite of services through market insight and analysis, registration, reimbursement, patient support, medical information, and pharmacovigilance. With over 18 years of experience & a team of over 90 employees – what we do – and the consistent excellence with which we do it – sets us apart from other consultancies.
Commercial Eyes has a unique opportunity for an experienced Pharmacovigilance Professional to lead our Drug Safety team. In this role, you will be responsible for the delivery of our client’s patient safety services and related projects across drugs, devices and consumer goods with Australia and New Zealand. This is a challenging and senior role in the organisation. Crucial to the role is the development of strategic plans to drive growth in this key business area.
The Pharmacovigilance Manager must ensure that each Client’s pharmacovigilance service or project is delivered according to best GPV practice and in accordance with contractual agreements. This includes the implementation, maintenance, and improvement of pharmacovigilance systems at Commercial Eyes.
- Maintain and build successful client and industry relations.
- Provide strategic advice on pharmacovigilance related matters to clients including ASA annex to EU RMPs including the operationof commitments.
- Lead internal, external and client pharmacovigilance audits.
- Oversee day to day operational activities including, Adverse Event reporting, drug safety programs, patient safety monitoring programs across pharmaceuticals, devices, complementary medicines, and consumer goods.
- Training client’s staff and their third-party partners on safety reporting.
- Monitoring compliance to project and CEPL pharmacovigilance key performance indicators (KPIs). Undertake RCA and CAPA’s where deviations are identified.
- Manage the performance and development of the Drug Safety Team.
- Contribute to the formulation of annual financial objectives and budgets.
- The incumbent will, in addition, need to comply with Project Specific Responsibilities (PSR) as stipulated in individual Client project(s). Implementing new projects into the PV function as agreed.
- As a consulting role, responsibility also includes project billing.
- When acting as QPPV be contactable as per clients requirements, this may include out of business hours requirements.
- Qualifications in a scientific discipline such as pharmacy, pharmacology, nursing or drug development.
- 5 years plus industry experience in a Drug Safety Role, preferably with exposure to leadership
- Knowledge of, and experience with PV compliance audits.
- Experience with TGA and Medsafe Prescription, Listed and complementary medicines and Devices.
- Detailed knowledge and understanding of 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.
- Highly developed communication, organisational and problem-solving skills.
- Demonstrated experience managing quality management systems.
- Demonstrated experience with Microsoft Suite and PV databases.
- 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.
- Commercial Eyes does not accept applications from recruitment agencies.
- To apply for this role you must be a permanent resident or citizen of Australia.
Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.
This role is based in Melbourne.
If you would like more information, call our People, Learning & Performance department on 03 9251 0777.