Global trade analyst állások, munkák egészségügy, gyógyszeripar területen

Organize and coordinate internal and external learning and training activities - from planning and scheduling to attendance management and training evaluation. ...

Investigating and understanding the manufacturing processes and used raw materials, as well as troubleshooting issues and improving process efficiency....

• Location: Budapest, Hungary, 9th District, Mill Park office building
• Job Type: Full-time
• Normal office hours
• Hybrid work mode

• 40 hours per week
• Normal business hours
• Office attendance: Once a week
• Tracking different regulatory submissions in the corporate regulatory database – update database with specific documents and/or information
• Running daily queries, providing reports to client stakeholders

Lead the implementation of quality systems and processes for the new facility, ensuring compliance with ​IATF 16949 and ​customer-specific standards (e.g., VDA 6.3, Formel Q, BMW QM-Requirements)....

• Literature reviews as requested by client epidemiologists using the best practice methodologies
• Literature search and preparation of Literature review report for Pharmacoepidemiology
• Perform peer Scientific & Technical Review

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Location: Budapest, Hungary – 9th District, Mill Park office building
• Job Type: Full-time
• Contract: Maternity cover (until the incumbent returns)
• Office Presence: Required once per week

• QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements.
• Case intake activity for ICSRs related performance during the work.
• Ensure the Quality and TAT targets are defined and met.

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials