Pharmacovigilance Specialist

6 months ago

Sydney, Australia Guerbet Full time

Guerbet is a human-scale company that aims to become a new global leader in medical imaging.
Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.

The company offers a comprehensive range of CT scan, Cath Lab, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostic (IRT) products, along with a range of injectors and related medical devices to improve patients' diagnosis, prognosis and quality of life.

More than 60,000 health professionals rely on Guerbet's contrast agents. Advancing in innovation solutions, the diagnosis of major diseases (cardiovascular diseases, cancers, diseases of the central nervous system) and interventional radiology while reconciling efficacy and cost containment, are at the heart of Guerbet's mission.

Its total workforce is of 2,700 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

(Geographical perimeter = Australia and New Zealand)
Pharmacovigilance

**I - Common missions related to the function**:
Participates to the scientific and international regulatory intelligence. Provides expertise and support to analyze the impact of new scientific or regulatory information.
Updates the quality documentation within the Guerbet Australia PV documentation system.
Checks the compliance to quality referential for the perimeter.
Participates to the preparation and conduct of vigilance audits and inspections. Participates to the implementation and follow-up of corrective and preventive actions.
Elaborates and/or contributes to the elaboration of training materials related to the field of activity.
Informs the Regional vigilance manager/EU-QPPV/UK-QPPV/Head of Global Vigilance of the Group of any emerging issue, any incident or any information which may influence the security of the medicinal products or the medical devices or may need to be reported to competent authorities.
II - As LRPPV (local responsible person for pharmacovigilance) /LRPMV (local responsible person for medical device vigilance)
Act as LRPPV and LRPMV responsible for Pharmacovigilance and Medical Device Vigilance system management in Guerbet Australia
Is responsible for ensuring that Guerbet Australia and local distributors/partners comply with PV/MDV obligations, by implementing the vigilance agreements (SDEA and MDVA) and their subsequent amendments and ensuring their compliance with the quality documents and the local regulations.
Ensure the compliance of below Vigilance operations.

Pharmacovigilance (PV) / Medical Device Vigilance (MDV) case management
Collect local PV/MDV cases (reports of Adverse Drug Reactions (ADRs) / Adverse Events (AEs) / special situations / incidents) from healthcare professionals, patients, scientific and medical literature, competent authorities’ websites, medical information enquiries (MIEs), product quality complaints (PQCs), customer relationship management (CRM) tool, market research programs, and clinical studies etc.
Report to Global Vigilance department the PV/MDV cases collected as well as requests for information from competent authorities.
Perform a local medical assessment of the PV/MDV cases, report them to local competent authority with data processed by Global Vigilance department.
Record the PV/MDV cases in the Affiliate PV/Complaint case log.
Perform follow-up activities for local PV/MDV cases.
Perform local searches of PV/MDV cases in the published literature, including the collection of follow-up information from the authors.

Interactions with healthcare professionals and competent authorities
Submit periodic safety reports, response documents, and any information regarding changes in benefit/risk ratio of the products to the appropriate competent authorities.
Submit product risk management plans to competent authorities and manage risk minimization activities.
Answer to product-related safety questions from healthcare professionals with the support of the Global Medical Information department.
Report safety information to healthcare professionals via the PV/MDV Contact Persons of the distributors.

O ther PV/MDV-related operations
Is responsible for the signature and implementation of a Safety Data Exchange Agreement (SDEA) / Medical Device Vigilance Agreement (MDVA) between the Guerbet Australia and the Global Vigilance department.
Is responsible for the signature and implementation of Local SDEAs / Local MDVAs with all partners in charge of product distribution and/or promotion.
Ensure PV audits are conducted at partners’ level.
Perform reconciliations with other data collection systems (MIE, PQC, CRM, swi

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