What is a QPPV?
A Qualified Person for Pharmacovigilance is the main person responsible for the pharmaceutical company meeting its legal obligations for monitoring the safety of their products in the marketplace.
What are their roles and responsibilities?
A QPPV has a challenging role as they need complete oversight within the company and be able to manage benefit:risk information from a variety of different departments.
They have a number of important responsibilities:
- A point of contact for the EU regulatory authorities regarding product risk:benefit
- Ensure that the Marketing Authorisation holder has an adequately functioning pharmacovigilance system in place
- Oversee activities impacting on PV such as signal detection, quality assurance, safety database and SOPs. Prepare for audits
- Assess and oversee training relevant to PV
What are the QPPV requirements?
The QPPV you choose needs to have appropriate qualifications and documented evidence of their training. They additionally need to be medically qualified or if not have access to someone within the company who is.
Why is it important to choose the right QPPV for your company?
This is a vital function for your business, to ensure you’re meeting all legal and regulatory requirements. If there was to be an issue, patient safety could be compromised and the resulting regulatory action and press could be incredibly damaging to your company’s reputation.
How can Essjay Solutions help?
We can provide you with highly experienced QPPV professionals who are able to hit the ground running. We’re aware of how important it is to have a proactive professional with the knowledge to oversee everything from appropriate management meetings to assessing gaps and rectifying these through process improvements and training.