New roles! We are currently seeking 2 new positions in our Global Safety team. Reporting directly into Singapore, you will be the local expert and main point of contact for all Pharmacovigilance activities. These roles can be based in Sydney or Melbourne, and we offer hybrid and flexible work options. We are open to the right person, and ideally, you will have a minimum of 2 years prior local experience in this area and a sound understanding of the Therapeutic Goods Administration (TGA).
As part of this interview process, you will be required to complete a video screening interview. Please only apply if you hold current full work rights for Australia, as we cannot consider part-time or sponsorship for this role.
Essential FunctionsPrimary Contact: Serve as the main contact for pharmacovigilance inspections and liaise with Competent Authorities.
Business Continuity: Ensure back-up coverage during absences.
Regulatory Awareness: Stay updated on local regulatory requirements and promote pharmacovigilance within the organization.
Requests & Evaluations: Respond promptly to Competent Authorities' requests regarding medicinal products.
Project Management: Understand project budgets and scopes, maintain project materials, and collaborate with team members.
Issue Resolution: Identify issues, propose solutions, and respond effectively to requests.
Reporting: Provide regular updates and reports to project managers and the EU QPPV/designee.
Safety Data: Ensure timely collection and reporting of safety data and periodic reports.
Local Literature: Monitor local journals for relevant safety information.
Risk Management: Oversee local risk minimization measures and support the development of corrective actions.
Compliance: Support audits, inspections, and local compliance interventions.
Documentation: Review and approve risk management plans and periodic safety update reports as needed.
Pharmacovigilance Agreements: Provide input to local agreements and manage local pharmacovigilance system master files.
Clinical Studies: Ensure pharmacovigilance input to clinical study protocols.
Ad-hoc Activities: Perform other tasks as directed.
QualificationsBachelor's Degree in biomedical science or related area(s).
At least 2 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc.) with project management experience. Equivalent combination of education, training, or experience.
In-depth knowledge of applicable global, regional, and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
In-depth knowledge of the pharmacovigilance legal framework in the country where LQPPV services are delivered.
In-depth knowledge of relevant Standard Operating Procedures (SOPs).
Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
Excellent analytical and problem-solving approach when interpreting safety reports, literature, and undergoing inspections.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
#J-18808-Ljbffr
