The European Union Qualified Person for Pharmacovigilance shall be responsible for the establishment and maintenance of the company’s PV system and therefore 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.
Hence, the EU QPPV should have access to the PSMF and be 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 EU QPPV’s responsibility.
The EU QPPV is also responsible for :
Establishing and maintaining pharmacovigilance (PV) system, including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities
Overseeing the safety profiles of company’s marketed products and any emerging safety concerns
Acting as a single point of contact for the EMA and EU Competent Authorities on a 24-hour basis, and the contact point for inspections
Ensuring and verifying that the pharmacovigilance system master file (PSMF) is constantly an accurate and up-to-date reflection of that safety system
Contribute to the establishment and maintenance of Pharmacovigilance (PV) System, which ensures that information about all suspected adverse reactions which are reported to the personnel of the Company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community.
Develop and maintain the Pharmacovigilance System Master File (PSMF) ensuring that the PSMF is an accurate and up-to-date.
Provide oversight over the functioning of the PV system in all relevant aspects. Oversee development and implementation of standard procedural documents and processes as they pertain to the function of the EU QPPV.
Participate as a standing team member in the preparation an approval of aggregate reports, Risk Management Plans (RMP), providing medical input to risk minimisation measures, RMPs and aggregate reports.
Provide 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).
For requests from Competent Authorities, the EU QPPV will collaborate with the Company colleagues on the response strategy, development and approval.
Review and approve including sign-off of protocols of post-authorisation safety studies conducted in the European Union (EU) or pursuant to a RMP agreed to in the EU.
Ensure full and prompt response to any request from Competent Authorities for the provision of information necessary for the benefit-risk evaluation of the products in collaboration with relevant departments.
Ensure that the conduct of PV and submission of all PV-related documents is in accordance with legal requirements and Good Pharmacovigilance Practice.
Ensure the necessary quality, including the correctness and completeness, of PV data submitted to the Competent Authorities in Members States and the Agency.
Act as single point of PV contact for Competent Authorities in Member States and the Agency and MAH on a 24 hour basis and as a contact point for PV inspections.
Promote, maintain, and improve compliance with PV legal requirements and maintain up-to-date knowledge of current PV regulations.
Ensure Back-up procedures are appropriately maintained and tested including PV Business Continuity, Disaster Recovery, and Deputy EU QPPV.
Lead by example to ensure effective and cooperative cross-functional teamwork at the country, regional, and global levels.
Ensure compliance with all relevant regulatory and legal requirements and with MAH’s Code of Business Conduct and Ethics.
Maintain up to date knowledge of current regulations and collaborate with Global PV on regulation changes.
Have the authority to make changes to the PV system.
Participate in all relevant meetings or committees of MAH and / or contractual arrangements.
Have an overview of medicinal product safety profiles, any emerging safety concerns, any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products and other relevant finding raised from studies / programmes conducted by the Company.
Keep up to date with data or reports generated from databases and other systems.
M.D. or basic medical training or other education
PV experience and / or previous experience as Deputy EU QPPV
Solid knowledge of PV system operations and function
Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing
Strong operational and managerial skills as demonstrated by leading previous
projects or functions
Maintain high ethical standards, including a commitment to the Company's values and behaviours
Strong oral and written English communication skills
Common using Word, Excel, Power Point, Internet