Sr. Pharmacovigilance Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary:

• Maintain, in collaboration with EUQPPV, Global Patient Safety (GPS), EMEA & LATAM Pharmacovigilance Director and WE Pharmacovigilance Manager, an efficient local Pharmacovigilance system in Greece in compliance with the company procedures and applicable legislation
• Management of Safety Data Exchange Agreements in EMEA region.

Essential Duties and Responsibilities:

National Qualified Person for Pharmacovigilance

1. Local Pharmacovigilance System

• Reviewing PSMF, when requested by Regional PV Director/WE Manager
• Performing e-submission to Cypriot Health Authorities of data relating the volume of sales for all pharmaceutical products marketed in the Republic of Cyprus
• Support Cluster Medical Affairs Organization, and/or local Regulatory Affairs in the answers to safety questions from the Health Care Professionals as needed
• Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster or multiple cases for one batch received in a short frame) and escalate as per procedures
• Have overview of the local safety communications exchanged internally
• To ensure local business continuity with respective back-up according to applicable procedures
• To participate to the 24h coverage for MoH communications
• Act as the main contact point for EOF in regards the EXTRANEAL communication tools part of product’s Risk Management Plan and be responsible for submitting the dissemination status on an annual basis
• Be an active member of the PV subgroup of SFEE (Greek pharma association).

2. Adverse Event Reports

• Collect, document, follow-up and transmit all local Adverse Events (AEs) and other safety information to Patient Safety Organization and archive, in accordance to applicable procedures.
• To close and archive ADR reports according to applicable procedures
• Answer queries from global patient safety (GPS) organization and to use the specific follow-up questionnaires
• Answer any questions, subsequent to submission of local cases to Eudravigilance in liaison with the GPS organization.

3. Audits and inspections

• To actively participate to the inspection/audit preparation, and provide document requests
• In coordination with the cluster PV Director, EU-QPPV office and GPS, to investigate and provide/ support responses to inspection and audit findings and implement preventive /corrective actions.

4. Interventional and non-interventional local studies activities

• Inform the QPPV office and the SE PV Cluster Coordinator for any new interventional and non-interventional local study and transmit the protocol
• Review the safety section of interventional and non-interventional local studies (Post Authorization Safety Studies) to ensure that is compliance with national PV requirements.

5. Agreements with third parties

• Collaborate with agreement owners, country QA and with the EMEA PV agreements team to ensure that any relevant Agreement with Third Party include appropriate PV clause or full SDEA
• Support the EMEA PV Agreement team in the implementation of local PSPs/MRPs, in collaboration with the initiator
• Notify safety signals to third party (distributor or PV supplier) in country/cluster as per procedure
• Perform reconciliation of Adverse Events with Third parties/PV Service Providers.
• Train/archive on pharmacovigilance procedures any PSP/MRP parties bounded with KCo with safety agreements in Greece and Cyprus with agreed   frequency as indicated in agreement,

6. Regulatory Intelligence

• Local regulatory intelligence: To regularly screen the website of Competent Authorities for safety signals, Pharmacovigilance newsletters, regulations, etc.
• Inform Pharmacovigilance Director, WE Manager, EU QPPV and GPS on relevant changes concerning National regulations in accordance to applicable procedures.

7. Interactions

• Ensure appropriate contact with country lead and other interfaces not limited   to country regulatory affairs, country quality assurance, business units,healthcare professionals and competent authorities in Greece and Cyprus
• Bring safety expertise and advice to business and other local functions.

8. Compliance

• Monitor and ensure local compliance, make efforts to achieve high compliance rates
• To open process errors according to applicable procedures and provide assistance in the resolution of noncompliance reports
• Initiate and follow of a CAPA, if needed.

9. Activities related to other countries in EMEA region:

• Provide support to countries in the region in different aspects of pharmacovigilance as requested. Support may include intake in PSS of safety reports and other safety information during back up coverage or tasks  managed in regional level.

Management of PV Agreements in EMEA

• Communicate and negotiate directly with co-developers/co- marketers/partners regarding development, implementation and maintenance of Regional/Local Pharmacovigilance Agreements (PVAs).
• Collaborate with other Vantive businesses/functions and Global Patient Safety (GPS) to ensure that:

– New/planned business/commercial relationships are notified to GPS

– Agreements appropriately address PV obligations.

– Support planning, development, and maintenance of training material

Qualifications:

• Knowledge of pharmacovigilance database
• Ability to work with cross-country and multicultural team
• Detail-Oriented: Strong attention to detail in managing PV activities, documentation, and training records 
• Ability to work under strict timelines
• Collaboration skills and ability to work in virtual environment
• Experience in working in a multinational team environment

Education and/or Experience:

• Academic degree in life science, pharmacy or any related field.
• 3+ years of experience in the field of Pharmacovigilance 
• Fluent in Greek and in English both in oral and written

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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