Pharmacovigilance Specialist

4 weeks 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

  • Pharmacovigilance Specialist

    2 months ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits** - Lead PV/MDV compliance, contributing to product safety and regulatory excellence. - Dynamic work environment with a focus on professional development and work-life balance. - Competitive salary package + company benefits **About the Company** My client is a global pharmaceutical company specializing in innovative medical products. They have a...

  • Pharmacovigilance Specialist

    2 days ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits** - Lead PV/MDV compliance, contributing to product safety and regulatory excellence. - Dynamic work environment with a focus on professional development and work-life balance. - Competitive salary package + company benefits **About the Company** My client is a global pharmaceutical company specializing in innovative medical products. They have a...

  • Pharmacovigilance Specialist

    2 months ago

    Sydney, Australia BOEHUNTER HEALTHCARE & LIFE SCIENCES Full time

    **BOEHUNTER HEALTHCARE SEARCH** An exciting opportunity to join a Global Pharmaceutical organisation who is well-known in life-transforming treatments in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. **To be successful in this role you will be able to demonstrate**: - Bachelor’s level...

  • Pharmacovigilance Specialist

    3 weeks ago

    Sydney, Australia BOEHUNTER HEALTHCARE & LIFE SCIENCES Full time

    **BOEHUNTER HEALTHCARE SEARCH** An exciting opportunity to join a Global Pharmaceutical organisation who is well-known in life-transforming treatments in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. **To be successful in this role you will be able to demonstrate**: - Bachelor’s level...

  • Pharmacovigilance Specialist

    1 week ago

    Sydney, New South Wales, Australia BOEHUNTER HEALTHCARE & LIFE SCIENCES Full time

    BOEHUNTER HEALTHCARE SEARCHAn exciting opportunity to join a Global Pharmaceutical organisation who is well-known in life-transforming treatments in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.To be successful in this role you will be able to demonstrate:Bachelor's level degree or above in...

  • Pharmacovigilance Specialist

    1 week ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    Benefits Lead PV/MDV compliance, contributing to product safety and regulatory excellence. Dynamic work environment with a focus on professional development and worklife balance. Competitive salary package + company benefitsAbout the CompanyMy client is a global pharmaceutical company specializing in innovative medical products. They have a strong presence...

  • Pharmacovigilance Specialist

    1 week ago

    Sydney, New South Wales, 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...

  • Pharmacovigilance Specialist

    3 weeks ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits** - 3 month contract role within a global Pharmaceutical company - Attractive salary package/hourly rate - Hybrid opportunity to work from home and from the office **About the company** Our client is a global pharmaceutical company with a strong presence in Australia and New Zealand. Committed to enhancing and saving lives, they have a wide range...

  • Medical Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Medical Affairs Specialist | Sydney basedSydneyPharmaceutical / MedicalSydneyPharmaceutical / Medical Be part of a collaborative team working in a niche specialty care company, who's building a great team to work on pipeline products in the ANZ marketWork closely with experienced leaders in the medical affairs industry.Agile company with excellent visibility...

  • Medical Services Specialist

    2 weeks ago

    Sydney, Australia Viatris Full time

    Viatris Pty Ltd At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Bioinformatics Specialist

    2 months ago

    Sydney, Australia mexec careers Full time

    Clinical Diagnostics - NGS - Data Analysis **The Client** Backed by significant Venture Capital funding, our client is a biotech start-up developing innovative technologies poised to transform the industry’s approach to quality control and longitudinal monitoring of clinical molecular diagnostics. Key to this strategy is the expansion of their widely...

  • Genomic Specialist

    2 months ago

    Sydney, Australia mexec careers Full time

    Clinical Diagnostics - NGS - Product Development **The Client** Backed by significant Venture Capital funding, our client is a biotech start-up developing innovative technologies poised to transform the industry’s approach to quality control and longitudinal monitoring of clinical molecular diagnostics. Key to this strategy is the expansion of their...

  • Specialist Patient Safety

    1 week ago

    Sydney, New South Wales, Australia Sandoz Full time

    70 million With over 70 million packs across 600 product lines - make a mark on every patient experience. Be part of a team that ensures quality use of medicines for the fastest growing generic in Australia. Come work for a team that feels supported and challenged by their peers and learning and growing together is part of our culture. Those joining Sandoz...

  • Medical Services Specialist

    1 month ago

    Sydney, Australia Viatris Full time

    Viatris Pty Ltd At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of...

  • Medical Services Specialist

    1 month ago

    Sydney, Australia Viatris Full time

    Viatris Pty LtdAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access – Providing high quality trusted medicines regardless of geography...

  • Medical Services Specialist

    3 weeks ago

    Sydney, Australia Viatris Full time

    Viatris Pty Ltd At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of...

  • Medical Services Specialist

    1 week ago

    Sydney, New South Wales, Australia Viatris Full time

    Viatris Pty LtdAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines regardless of geography or...

  • Pv Specialist

    1 week ago

    Sydney, New South Wales, Australia Guerbet Full time

    Press Tab to Move to Skip to Content Link At Guerbet, we build lasting relationships so that to enable people to live better.This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging.As a pioneer in the field of...

  • Bioinformatics Specialist

    1 week ago

    Sydney, New South Wales, Australia mexec careers Full time

    Clinical Diagnostics NGS Data AnalysisThe ClientBacked by significant Venture Capital funding, our client is a biotech start-up developing innovative technologies poised to transform the industry's approach to quality control and longitudinal monitoring of clinical molecular diagnostics. Key to this strategy is the expansion of their widely published...

  • Genomic Specialist

    1 week ago

    Sydney, New South Wales, Australia mexec careers Full time

    Clinical Diagnostics NGS Product DevelopmentThe ClientBacked by significant Venture Capital funding, our client is a biotech start-up developing innovative technologies poised to transform the industry's approach to quality control and longitudinal monitoring of clinical molecular diagnostics. Key to this strategy is the expansion of their widely published...