Pharmacovigilance Specialist with German

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.

Role overview

As Pharmacovigilance Specialist you will maintain the regional Pharmacovigilance system in ECEMEA region in compliance with the company Pharmacovigilance procedures and national regulations. Act as Deputy Contact Person for Pharmacovigilance Poland. Act as Deputy Local Responsible Person for Pharmacovigilance for the region of Germany and Switzerland, and as Deputy Contact Person for Pharmacovigilance for Austria.

What you'll do

• Management of Adverse Event and Other Safety Information

• Case intake process in Pharmacovigilance Safety System (PSS) - understand AE report process in PV database and register cases in PSS from all sources within timeline in accordance with internal procedures and national legislations.
• Determine a need to initiate follow-up with the reporter and manage the process for the collection of information
• Submission of adverse events reports to partners and/or Competent Authorities in the ECEMEA region
• Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures
• Perform reconciliation of adverse events with third parties/PV Service Supplier, including PSP/MRP.

• Compliance
  
• Closely monitors compliance and ensures all efforts are made to achieve high compliance rates
• Open and complete non-compliance reports and assist in resolution of noncompliance reports.

• Training management

• Arrange and monitor PV training for third parties, including but not limited to MRP/PSP programs.

• Acting as a back-up for DACH (Germany, Austra, Switzerland) region

• Act as Deputy Local Responsible Person for Pharmacovigilance for the region of Germany and Switzerland, and as Deputy Contact Person for Pharmacovigilance for Austria.
• During the absence of the Local Responsible Person for Pharmacovigilance, the Deputy is accountable and responsible for the following activities:                                                                                                                                      

• To be involved in communication on PV topics with local Competent Authorities, and support answers preparation.                                                                                                                        
• To provide the national Competent Authorities with any information relevant to the benefit/risk evaluation of Vantive products in collaboration                                                                                                             
• ADR and signal reporting.        

• Activities related to associated countries in the EMEA region

• Collaborate closely with the EMEA PV team members on Pharmacovigilance activities and provide any relevant information or support. 
• Collaborate closely with the ECEMEA PV Manager on Pharmacovigilance activities in the region and provide any relevant information or support. 

• Audits and Inspections

• Assist and participate in Pharmacovigilance inspection readiness activities. 
• In coordination with the ECEMEA PV Manager, EU/UKQPPV and Global Patient Safety team, to investigate and provide/support responses to inspection and audit findings and implement corrective actions. 

What you'll bring

• 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
• Willingness to gain additional knowledge and activities in the field of Pharmacovigilance.

Education and/or Experience:

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

We offer

• The probation period of 3 months and then for an indefinite period.
• Competitive salary, and recognition award program.
• A company culture that is based on our values: collaboration, speed, courage, and simplicity.
• Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
• Package of benefits including Private medical care (Lux Med), Life Insurance, and Multisport card.
• Holiday Bonus, Annual Bonus, Newborn baby Bonus, Christmas Bonus.
• Co-financing for corrective glasses and lenses.
• Cafeteria/lunch cards (300 PLN monthly).
• PPE program with very attractive conditions available for each employee after 3 months.
• Fully covered language courses (English or other languages according to business needs).
• Co-financing of holidays and an additional 2 days off from work annually.
• Additional extra day for a birthday!
• Annual Award related to Company Cultural Values.
• Recommend a friend - Referral Bonus.
• Great Warsaw office location - Powiśle!

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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