PV Specialist - Sydney, Australia - Guerbet

Guerbet Sydney, Australia

4 days ago

Long-term/regular

Description

PV Specialist

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 contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve , Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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.

Other 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, switch board/customer service...).

Set-up a local system for the detection and management of safety signals, emerging safety issues, significant safety issues, public health threats.

Ensure local regulatory intelligence on PV/MDV matters.

Ensure business continuity in PV/MDV activities at affiliate level.

Ensure global oversight on the local PV system through Safety Board meetings.

Ensure regular PV/MDV training of the Guerbet Australia staff as well as PV Contact Persons of the partners.

Participate in the revision of the safety sections of the Australia Product Information and New Zealand Data Sheet in collaboration with local Regulatory Affairs.

Participate in the creation/revision of local PV/MDV SOPs.

Ensure the control of safety operations through self-inspections.

Record and store safety data and documents in secured formats and repositories.

Organise regular meetings with internal stakeholders (safety board meeting etc) to monitor PV compliance.

II- Specific missions for this position

Acts as qualified person responsible for pharmacovigilance in Australia (QPPVA) as required by TGA regulation and ensure the Guerbet Australia affiliate has an effective PV system in place and complies with the legal PV requirements for Guerbet medicinal product.

Is the Contact Person of the Australia and New Zealand competent authorities for any vigilance matter related to Guerbet products.

Quality Assurance

Maintain the established Quality Management System (QMS) in accordance with ISO9001 regulations. This includes, but not limited to, quality processes for complaints, deviation, CAPA, change control, self-inspection, training etc.

Coordinate and document quarterly QMS meetings.

Coordinate responses to local Product Quality Complaints (PQCs) with the global Product Monitoring department.

Coordinate local product labelling rework process for Nemoto and other medical devices, as needed

Manage NCR for Guerbet AU and local Returns process and collaborate with Customer Service team to assess product release.

Inbound GDP release for shipments with issues (temperature assessment, damage, suspicion of theft etc.)

Quality Management Review (Local Affiliate and with TPL (UPS) – be able to present / discuss of the local quality issues and work with UPS to find solutions if needed)

Manage the training of the local affiliate (via new LMS) to ensure the key stakeholders are trained and up to date in their trainings.

Management of the local batch recall process

Contact person for Health Authority inspection.

Regulatory

Prepare and submit regulatory applications to Health Authorities according to target timelines.

Follow up amendments related to product variations to meet regulatory compliance.

Update and maintain the regulatory documentation system.

Effectively maintain communication with Health Authority and other internal and external stakeholders.

Requirements:

Pharmacist or nurse required

Minimum 2 years' experience in pharmaceutical company (PV experience preferred)

Proficient verbal and written English skills

Strong communication, analytical and systems skills.

Attention to detail and ability to multi-task

Proficient in MS Office, including Word, Excel and PowerPoint

Work systematically according to regulations

High responsibility on duties

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,

Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,

Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. or you can also call this number

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