Richter Gedeon Nyrt. / Magyarország
Pharmacovigilance Manager
This job is now closed
Job Description
- Req#: 8344
- Manage all Global Patient Safety (GPS) department related quality and compliance activities for programs in development and post approval, including establishing compliance metrics and compliance monitoring
- Perform review and approval of unplanned process deviations, quality events and associated CAPAs in the eQMS.
- Leading Root cause investiagtions
- Facilitate SOP and guidelines development and revisions, as well as training
- Manage inspection readiness activities and participate in audits
- Supporting the development and maintenance of Pharmacovigilance System Master File (PSMF).
- Lead process improvements projects within GPS
- Independently organizes, conducts and/or facilitates meetings
- Escalate issues appropriately
- Other duties as assigned
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BA/MS degree with 1+ years’ experience in the pharmaceutical industry in Pharmacovigilance/Regulatory.
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Able to chair meetings, present orally in English and interact with business partners.
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Knowledge of GVP modules
Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!
Our founder, Gedeon Richter's dream of a successful international pharmaceutical company still lives today. And we take it to the next level every day by discovering new active pharmaceutical ingredients and introducing new medicines that improve the quality of life for many people around the world.
Gedeon Richter is looking for a committed and experienced professional for the position
Pharmacovigilance Manager
Purpose and Scope
This role is responsible for Pharmacovigilance (PV) Compliance and strengthening and advancing Richter Gedeon’s (Richter) pharmacovigilance quality management system. This person has a level of knowledge and experience of appropriate GxP compliance and other applicable regulations and laws. You are flexible and initiative and be able to demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.
Essential Job Responsibilities:
What You’ll Bring
We offer
You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
• Challenging, responsible professional work
• Opportunity for continuous development
• Long-term employment in an innovative and secure workplace
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Extensive benefits packageThe Richter community is looking forward to your application.
About the company
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