Pv Compliance Specialist, Prague

Publikováno 2023-11-21
Vyprší 2023-12-21
ID #1931105618
Pv Compliance Specialist, Prague
Czech Republic, Hlavní město Praha, Prague,
Publikováno November 21, 2023


This is where you save and sustain livesAt 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 therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.Summary Monitor the performance and effectiveness of company’s pharmacovigilance system.Track pharmacovigilance (PV) process errors and initiate corrective and preventive actions per company’s quality system requirements. Oversee PV process errors, Corrective and Preventive Actions (CAPAs) and monitor their effectiveness. Present PV compliance metrics in regular meetings. Support PV inspections and audits. Support Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF).ESSENTIAL DUTIES AND RESPONSIBILITIESMonitor PV compliance based on expertise and/or regulatory requirements, internal processes and external business partner obligationsEnsure tracking of process errors (PEs) occurring during pharmacovigilance operationsInitiate non-conformance reports (NCRs) and CAPAs per Global Patient Safety (GPS) CAPA review board decisions, monitors PE/NCR/CAPA status for GPSPrepare PV compliance metrics, manages regular PV compliance meetings and provides updates to GPS managementProvide compliance data input for Pharmacovigilance System Master File (PSMF)Assist to conduct effectiveness checks and internal assessments of current PV processes to identify further improvement opportunitiesAssist in development, generation, evaluation and monitoring of internal/external compliance metrics during PV Audits and InspectionsREQUIREMENTSBachelor’s degree in a biologic/medical/clinical or equivalent fieldFluency in EnglishPrevious (minimum 2 years) experience in pharmacovigilance including basic understanding of PV complianceUnderstanding and ability to interpret good pharmacovigilance practices (GVP) and other PV regulationsDetailed oriented, readiness to meet deadlines and work in a global team environmentPC skills: advanced working knowledge of Microsoft office. Experience with Trackwise is an advantageExcellent time management, communication and problem solving skillsWHAT WE OFFERCompetitive salary, annual bonuses, recognition award program.Corporate culture 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.Company mobile and laptopLife insuranceMeal vouchers 100 CZK per day, all covered by Baxter1 week of holiday above state requirement (5 weeks in total)3 sick daysPension fund contribution (3% of gross salary)Benefits card and cafeteria systemReasonable Accommodations

Podrobnosti o práci

Typ práce: Plný úvazek
Typ smlouvy: Trvalý
Typ platu: Měsíční
obsazení: Pv compliance specialist

⇐ Předchozí zaměstnání

Další práce ⇒     


Kontaktujte zaměstnavatele

    Informace o zaměstnavateli


    Rychlé hledání:


    Zadejte město nebo region

    Klíčové slovo