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Pharmacovigilance Manager, Budapest

Utolsó frissítés 2024-06-21
Lejár 2024-06-21
ID #2181402471
Pharmacovigilance Manager, Budapest
Hungary, Budapest, Budapest,
Módosított June 4, 2024


Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.

It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.

Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day.

An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

We are looking for a qualified and motivated candidate for the role of Pharmacovigilance Manager based in Budapest.

The main purpose of this position is establishing and maintaining a domestic Pharmacovigilance (PV) unit, being responsible for carrying out all PV activities as described in Global/Regional PV SOPs/WIs for Teva Hungary in collaboration with Global & Regional PV as well as local Commercial BU management.

Main responsibilities Acting as contact point with the local health authorities regarding safety matters of Teva's products.

Establishing and maintaining working relationships with local departments, interfacing with PV and local external contractual parties (Teva’s 3rd parties/service providers) that may receive adverse events, special situations or other safety information, or impact on other PV activities (including but not limited to: Portfolio/Business development (BD), Legal, Regulatory Affairs (RA), Medical Affairs (MA), Quality Assurance (QA), Sales & Marketing, Customer Services, Reception, Digital engagement, PSP, etc.) Ensuring that colleagues in Teva Hungary are familiar with the relevant Pharmacovigilance requirements, and that the PV activities and responsibilities are performed locally according to the required standard.

Ensuring that, when needed, appropriate out-of-office hours, back-up and business continuity arrangements are in place for the local PV activities.

Safety Reporting - collecting and processing Adverse Events/Adverse Drug Reactions (AEs/ADRs) and Special Situations from all sources in compliance with local and/or regional regulations and the applicable company SOPs and other.

Performing local literature search - ensuring that local literature search is done in addition to the Global literature search.

Periodic safety update reports (PSUR) and Company Core Safety Information (CCSI) - effectively collaborating with local Regulatory Affairs (RA) for alignment of local renewals in accordance with available periodic reports per Teva Periodic Reports & Risk Management Centre (TPC) planning and other.

Studies and other organized data collection schemes- being aware of all studies/other organized data collection systems (planned, active, completed) conducted in “Country.” Risk Management Plans and Activities- ensuring that all necessary PV activities and any additional risk minimization activities required locally for all RMPs are agreed with local authorities and carried out on time and other.

Agreements - establishing a local process to ensure that PV is informed of new, updated or terminated PV-relevant commercial and service provider agreements, ensuring documented PV vendor selection (due diligence) is performed for 3rd parties performing PV-relevant activities and other.

Reconciliation and Corrective Action and Preventive Action (CAPA) Regulations and Procedures - being up to date with relevant local and global regulatory requirements/SOPs and keep documented evidence of gap assessment against local legislation changes and other.

IT and PV system access - ensuring that electronic records relevant for PV are saved in a location covered by a local Disaster Recovery Plan (DRP) and other.

Candidate requirements University degree in Pharmacy, Medicine, or other life science relevant field In depth knowledge of European and Hungarian pharmacovigilance requirements Minimum 4 years of relevant experience in Pharmacovigilance Relevant experience in Regulatory, Quality, Clinical Trials areas would be a plus.

Fluency in English and Hungarian, both written and spoken Experience in working with matrix teams and close collaboration with local and global stakeholders.

Strong interpersonal and communication skills in cross-functional teams Working independently on PV-related topics Analytical abilities and a creative, solution-oriented style Flexibility and ability to work in a fast-paced, rapidly changing environment on multiple projects with tight deadlines.

Strategic thinking and high integrity, including strong ethical and scientific standards.

What We Offer Competitive salary Benefits packages with a great bonus system Dynamic and professional atmosphere Career development opportunities

Munka részletei

Munka típus: Teljes idő
Szerződéstípus: Állandó
Fizetés típusa: Havi
Foglalkozása: Pharmacovigilance manager

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