Senior Specialist PVReq # JR - 032581 Location Ljubljana, Ljubljana Job Category Patient Safety Date posted 01/06/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapiesare foundin almost every hospital worldwide, in clinics and in the home. Forover 85years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other.This iswhere you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
JOB DESCRIPTION SUMMARY
• Acting as Local Safety Responsible and single Baxter PV contact point for Slovenia and as a Baxter PV contact point for pharmacovigilance inspections.
• Within the frames of ECEMEA PS team acting as primary PV local contact responsible for all pharmacovigilance activities for assigned countries of responsibility in Central Europe, South-Eastern Europe and Turkey.
• Within the frames of ECEMEA PS team acting as PV back up contact responsible for all pharmacovigilance activities that may be needed to perform during backup period in Russia, CIS countries and Israel.
• To act as Baxter PV contact for vendors and distributors from assigned countries of responsibility.
• A significant part of the work constitutes the responsibility for interaction with and oversight of distributors and vendors in the countries of responsibility.
• Have overview of the Baxter pharmacovigilance system described in Pharmacovigilance System Master File (PSMF) concerning assigned countries of responsibility and update it accordingly. Wherever needed prepare and maintain local Pharmacovigilance system files.
• Collaborate with GPS, EU QPPV and ECEMEA cluster head to set up and maintain an efficient PV system meeting EU, regional and national regulations and in compliance with Baxter’s PV procedures.
• To be aware and updated on relevant national PV legislation and inform ECEMEA cluster head and global patient safety team about any relevant changes to the national legislation countries of responsibility.
• Ensure appropriate contact with country general manager and other interfaces not limited to country regulatory affairs, country quality assurance, business units and with healthcare professionals and competent authorities in countries of responsibility.
• Working closely with ECEMEA cluster head in each pharmacovigilance aspect.
• Outlining and representing Baxter corporate expertise and opinion towards local competent authorities.
• Support answering questions or requests related to pharmacovigilance from competent authorities in close collaboration with EUQPPV office and ECEMEA cluster head.
• Escalate to EMEA PV head, ECEMEA cluster head, EUQPPV and global patient safety any safety related issues arisen in countries of responsibility without delay.
• Performing 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.
• To be a member of the local pharma association and actively participate in meetings, if applicable.
• Development and maintenance of PV procedures in the countries responsible for and involvement with interfacing Baxter functions/business/distributors are key responsibilities to ensure compliance with internal and regulatory requirements.
• minimum Master’s degree in pharmacy or Medicine,
• experienced in health sector at least 2 years,
• drug safety or Pharmacovigilance experience in pharmaceutical company, health care or regulatory authority,
• Risk identification and problem solving.
• Sound basis of Scientific (Training/Communications) knowledge in multiple areas.
• Knowledge of regulations, and experience with interpretation and application.
• Excellent written and verbal communication, presentation, and facilitation skills.
• Strong negotiation skills.
Slovenian - Fluent
English - Fluent
Serbo-Croatian - Will be advantage
Basic knowledge required: Word, Excel, PowerPoint
Additional advantageous knowledge: ARISg, ARGUS
• Compliance with country specific requirements.
Temporary hire for 14 months (Replacement for maternity leave)
Master's Degree (±18 years) - Medicine, Master's Degree (±18 years) - Pharmacy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.