RA, QA & PV Specialist

Job Description

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Job Description

Role objective

The main role of the position is to perform Regulatory, Quality Assurance and Pharmacovigilance activities for the Takeda organization in Hungary. Regulatory activities will comprise the majority of the responsibilities, approx. 70% of the workload with Quality Assurance as a secondary focus of approx. 25% and the remaining tasks to be allocated to Pharmacovigilance activities, approx. 5%. The position reports to the Regulatory, QA and PV Manager in Hungary.

The detailed description of the activities are the following:

Regulatory Affairs

• Support global products or coordinate local product regulatory submissions
• Participate in update/review of Product Information, artworks, promotional and non-promotional materials
• Participation in label/packaging creation, review and approval processes
• Responsible for handling of lifecycle changes (maintenance of different databases, notification processes, and other relevant procedures)
• Provide regulatory input and advice on new product launches and other regulatory activities
• Maintain and develop appropriate positive contacts with regulatory government officials and with internal stakeholders
• Guarantee accuracy and adherence to local Regulatory Authorities legislation

Quality Assurance

• Act as deputy Quality Assurance responsible
• Responsible for the implementation of Global requirements and procedures and ensure alignment with local requirements
• Track and assess if local documents are compliant with local/global requirements
• Support inspections/audits and ensure audit/inspection readiness
• Manage LOC and vendor/partner quality issues (i.e. complaints, recalls, deviations)
• Maintain oversight of contracts and quality agreements on LOC level
  

Pharmacovigilance

• Acts as the Takeda Deputy Drug Safety Officer (DDSO) involved in 24/7 coverage for PV related matters in the LOC, aligned with the DSO
• Establishes and maintains a local PV system, records, and files updated in accordance with company procedures and local requirements
• Manages safety information (i.e. ICSRs) received from any sources in Hungary
• Ensures of applicable (global/local) Risk Management Plans (RMP) are in place and implements risk minimization activities relevant to the territory.
• Maintains oversight of local activities such as IISR, NIS, Market researches and Patient Support programs, as well as company-sponsored web-sites and digital media in order to ensure compliance with the pharmacovigilance requirements.
• Ensures PV audit/ inspection readiness at the LOC and participates in audits/inspections as appropriate

Requirements

• MSc degree in scientific discipline or applicable health sciences field (pharma, medical, biotech, chemistry, biology field)
• Experience in regulatory affairs (2-3 years); experience in quality assurance and pharmacovigilance is an advantage
• Both fluent Hungarian and advanced English is a must
• Experience of working in a matrix management environment
• Solid understanding of EU and local laws, regulations and industry codes related to RA, GVP experience is an advantage
• High ethical standards
• Excellent organizational and prioritization skills
• Ability to work independently, solve issues with a quality and compliance mindset, good conflict management
• Advanced process management skills
• Excellent communication and collaboration skills with external and internal stakeholders

Locations

Budapest, Hungary

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time