In accordance with applicable regional (e.g., EU) or local legislation, the QPPV shall be at the marketing authorization holder’s (MAH) disposal permanently and continuously, be responsible for the establishment and maintenance of the MAH PV system (globally, regionally, or locally as required by legislation), and shall have sufficient authority to influence the performance of the quality system and the PV activities and to promote, maintain and improve compliance with the legal requirements. This includes having access to the pharmacovigilance system master file (PSMF) and being in a position of authority to ensure and to verify that the information contained in the PSMF is an accurate and up-to-date reflection of the PV system under the QPPV’s responsibility.
In relation to the medicinal products covered by the PV system, specific responsibilities of the QPPV include:
- Having an overview of medicinal product safety profiles and any emerging safety concerns.
- Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products.
- Having awareness of risk minimization measures.
- Being aware of and having sufficient authority over the content of risk management plans.
- Being involved in the review and sign-off of protocols of post-authorization safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU.
- Having awareness of post-authorization safety studies requested by a competent authority including the results of such studies.
- Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP.
- Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the EMA.
- Ensuring a full and prompt response to any request from the competent authorities in Member States and from the EMA for the provision of additional information necessary for the benefit risk evaluation of a medicinal product.
- Providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the EMA.
- Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
- Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections.
- Medical qualification in an acknowledged medical school with sufficient experience in clinical medicine or life sciences graduate with relevant experience
- Adequate PV theoretical and practical knowledge to influence the PV system
- The QPPV should have a minimum 5 years’ demonstrated experience in managing or implementing PV systems
- The QPPV should have documented experience in all aspects of PV, in order to fulfil the responsibilities and tasks of the role
- Excellent interpersonal, verbal and written communication skills
- Good computer skills
- Leadership skills
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- Global General Liability Insurance
- Global Travel Insurance
- Internet costs are covered by TFS
- Flexible working schedule