EU QPPV (m/w/x) | Hessen | Personal Health Care
Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client is operating in more than 100 countries worldwide and has almost 100.000 employees.
What will your tasks as EU QPPV be?
- Review, provide input and approve PSURs, risk management plans and clinical overview supplements as relevant to the EEA
- Ensure review of signal management reports for products marketed in the QPPV region
- Maintain awareness and oversight of other functions / third parties involved in PV activities related to the relevant marketed products
- Work with the QPPV office and local QPPVs (via the QPPV office) to ensure that all regulatory requirements are met
- Ensure the development of basic safety profiles for products marketed in the geographic region as required
- Establish and maintain the pharmacovigilance system to ensure that all suspected adverse reactions are collected, evaluated, and collated to be accessible in one central location
- Maintenance of the PV System Master File and the quality management system, as necessary
- Ensure communication of changes in the risk/benefit profile to the relevant regulatory authorities
Your requirements as "EU QPPV "?
- Medical Doctor or MS/ Doctorate degree in Pharmacy or natural sciences
- Significant experience in drug safety/pharmacovigilance; previous experience as EU QPPV or Deputy EU QPPV
- Strong knowledge of global regulations and standards related to safety processing and reporting, safety monitoring and post-marketing compliance activities of the pharmaceutical industry
- Experience in managing quality issues in the marketplace
- Demonstrated success in dealing with contractual agreements with suppliers and distributors
- Corporate mindset with a modest attitude and the ability to influence and win over customers
- Consistent attention to details
- German and English: fluent in spoken and written
They will offer you?
- Unlimited contract with permanent position
- 40- 60% Remote
- attractive benefits package
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!