Ildikó Hajdu-Németh Md Email & Phone Number

Budapest, Hungary

Budapest, Hungary

Subject Matter Expert at Organizational Readiness Services for ARIS Global Life Sciences Clients. -Provide content expertise of LifeSphere MultiVigilance Safety Solution training materials and ensure its alignment with Industry Standard Practice (ISP) as well as the customer’s specific processes and configurations. -Provide direction on training design and.

Budapest, Budapest, Hungary

- Responsible for delivering regulatory intelligence as a service by overseeing a team of 6 Regulatory Intelligence Experts. - Ensure products strategies are supported to achieve optimum market access by monitoring the regulatory environment and communicating its impact to key stakeholders in the company.- Implement and improve knowledge-sharing.

Budapest, Hungary

- Improve alliance and communications across global medical division projects, with a focus on China and Commonwealth of Independent States (CIS) regions.- Pharmacovigilance (PV) Strategy Management, budget planning and tracking.- Establish and maintain operations optimization as Interim PV Case Processing Unit Head.

Budapest, Hungary

- Manage drug safety operations of Pharmacoviligance Department (41 employees) in full collaboration with the EU-QPPV (Qualified Person for Pharmacovigilance), reporting to the Chief Medical Officer. (Deputy: Jan 2014 - Aug 2015, Head: Sept 2015 - Dec 2017)- Ensure continuous quality compliance of Good Pharmacovigilance Practices (GVP) as defined by the.

Somerset County, New Jersey, United States

Spent 5 years raising 3 children, 2 boys and a girl.

Budapest, Hungary

Convert written material from Hungarian to English, ensuring that the translated version conveys the meaning of the original intention as clearly as possible. Focus on medical language.

Rahway, NJ, USA

• GROUP: Merck Research Laboratories, Clinical Research, Metabolism
• Manage global safety team with upper management based on project demands. Participate in interviewing and hiring process of clinical operations as required for global research projects.
• Provide medical expertise and implement standards for review of clinical trial and adverse experience reports for expectedness, accuracy, quality and clinical importance, relationship to the suspect product as well as.
• Submit reports to regulatory authorities according to FDA (Food & Dug Administration), international regulatory requirements, and Company objectives and timelines.
• Create and manage documents such as periodic safety update reports, clinical expert reports, clinical study reports, product labeling, risk management plans, literature review and product information, particularly if.

Rahway, NJ, USA

• GROUP: Merck Research Laboratories, Clinical Research, Metabolism
• Oversee the conduct of DPIV Inhibitor Phase II-III clinical trials in coordination with clinical monitors, including preparation of clinical operating plans and protocols, ordering clinical supplies, designing case.
• Support the Safety Officer in monitoring safety issues across the DPIV Inhibitor program by effectively performing the duties and responsibilities of Safety MPCS by comprehensively and consistently reporting adverse.

Rahway, NJ, USA

• GROUP: Merck Research Laboratories, Project Management, Metabolism
• Lead and implement Bulk Drug and Clinical Supplies scheduling processes to allow successful initiation and enrollment of Phase I, II and III studies.
• Co-manage Pre-Clinical Anti-diabetic Drug Project Team milestones and objectives by maintaining precise program timelines, managing review preparation, authoring meeting agendas and summaries, and steering execution of.
• Principal manager of resource database for project team and steward of pre-clinical and clinical resource analyses between all functional areas involved.

Greater New York City Area, USA

• GROUP: International Pharmaceutical Group, ZOLOFT/CNS Team
• Created medical research library system used by both the medical and marketing divisions of the Zoloft team.
• Managed timelines for local country Clinical Research Associates to ensure that pre-study visits are conducted in a timely manner.
• Conducted QA review of pre-study reports to ensure that pre-study visits were conducted in accordance with FDA, ICH and GCP/SOP guidelines.
• Participated in writing and designing Case Report Forms, Data Clarification Form procedures and Japanese clinical trial database.

Budapest, Hungary

• GROUP: Pediatrics AIDS Foundation
• Translator (Hungarian I English) of various international documents pertaining to grant acquisitions, educational flyers and official documents.
• Doctorate thesis based on experiences with three particular children and their families dealing with the issues of HAART (Highly Active Anti-Retroviral Treatment) such as compliance, side effects, costs, and the.
• Coordinated yearly grant requests to major European companies, containing budget summaries, project protocols, and summaries of previous year's accomplishments.
• Participated in AIDS Awareness Seminars presented by American and Western European medical communities, in order to implement the newest medical care and strategies.

Doctor Of Medicine (Md), English Program, Cum Laude

Bachelor Of Science (Bs), Pre-Medicine/Pre-Medical Studies, Biology / Biochemistry

Activities and Societies: Full performance scholarship to Duquesne University Tamburitzans Violin, Voice, Dance

High School Diploma, National Honors Society, 9-12

Precollege Music Training, Violin, Chamber & Orchestra, Voice, Theory & Ear Training, 4Th - 12Th Grade