In this exciting position we are seeking an experienced and motivated Pharmacovigilance and Medical Information Manager to join our dynamic team in Melbourne. In this role you will be responsible for Management of the pharmacovigilance/Medical Information department ensuring direct reports are adequately trained to perform their role.
- Maintain oversight of the Australian Pharmacovigilance System by acting as the local Qualified Person for Pharmacovigilance (QPPVA)
- Ensure the pharmacovigilance system in place is effective and complies with pharmacovigilance legislation and requirements for Australia and New Zealand
- Act as Line manager of Pharmacovigilance and Medical Information Associates
- Involvement in the company’s preparation and management of audits and inspections
- Provide up-to-date, high quality and relevant medical, technical, and pharmaceutical information on Vifor Pharma designated products to external and internal customers
- Develop in depth knowledge on Vifor Pharma products and provide advice as required within the organisation
- Provide expertise that support the organisation (e.g., material review and approval, trainings, contract support and ad-hoc scientific support)
- To provide technical support to marketing, sales and medical colleagues
- Maintain a local tracking system of Relevant Safety Information (RtSI) and conducting follow up activities for all RtSI in accordance with local procedures
- Maintain oversight over local pharmacovigilance contracts
- Oversight of organisation activities related to pharmacovigilance (e.g. Significant Safety Issues, RMP implementation, regulatory and label updates, recalls, ad hoc requests from regulatory agencies, CAPA management, signalling, contracts, staff training)
- Responding to ad-hoc requests from the regulatory agencies as required and ensuring readiness and support audit/inspection preparation and management.
- Ensure consistency and high quality of responses to enquires.
- Ensure a log of all Medical Information enquiries in the global database, compliant with policy and procedural documents.
- Keep local medical information procedures up to date and in compliance with local laws, regulations, guidelines and company policies and procedures.
- Support the organisation with material review, copy approval and scientific assessment.
- Deliver on-demand company training, for example, but not exclusively, on medical information.
- Ad-hoc support to medical affairs (e.g., publication planning, advisory boards).
- To line manage, mentor and develop the local staff
- Degree in science, pharmacy, pharmacology or related field.
- At least 3 years’ experience in pharmacovigilance and/or medical information.
- Demonstrated ability to evaluate medical scientific literature accurately and effectively
- Ability to communicate information clearly and logically, both orally and in written
- Experience of working in a customer focused environment
- Awareness of the local laws & regulations relating to the provision of medical information
- Advanced knowledge of pharmacovigilance related legislation and guidelines in Australia
- Fluency in English
- Advanced degree
- At least 4 years’ experience undertaking Pharmacovigilance and Medical Information management in a pharmaceutical organisation
- Previous line management experience
- Ability to work in a cross-functional matrix environment
- Knowledge and understanding of local regulations and codes
- Previous experience in medical writing and database administration
If you are interested and you are a strong team player, proactive, flexible with very good communication skills, processes & compliance as well as a strong commitment to quality, accuracy, as well as Knowledge of relevant legislation, guidelines and codes relating to pharmacovigilance, medical information, and medical affairs we would very much like to hear from you.