QPPV stands for Qualified Person for Pharmacovigilance, and a Graduated Plan Officer is responsible for implementing and managing a graduated plan, which is a risk management plan for a pharmaceutical product - New Brockton, United States - Omega Innovations

Omega Innovations
Omega Innovations
Verified Company
New Brockton, United States

3 days ago

Michael Johnson

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Michael Johnson

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Description

Qualified Person for Pharmacovigilance (QPPV) / Graduated Plan Officer

Job Description:

The QPPV will be responsible for overseeing the pharmacovigilance system, ensuring compliance with EEA regulations, and serving as a key point of contact for regulatory authorities to ensure the safety and efficacy of our pharmaceutical products.

The ideal candidate will have a deep understanding of pharmacovigilance systems and processes, Risk Management Plans (RMPs), and possess excellent communication skills in both English and German.

In this role, your responsibilities will include:

  • Acting as the Qualified Person for Pharmacovigilance (QPPV) as required by European legislation, ensuring the company's pharmacovigilance system is compliant with relevant regulations
  • Performing tasks of the Graduated Plan Officer (Stufenplanbeauftragte) including those under section 19 AMWHV
  • Reviewing and overseeing the preparation of Periodic Safety Update Reports (PSURs), PBRERs, and Risk Management Plans (RMPs), ensuring high-quality documentation and data integrity
  • Maintaining a thorough understanding of RMPs, staying updated with current practices and regulatory expectations
  • Supporting health authority inspections and
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