SUMMARY: The QPPV/Team Lead is responsible for establishment and maintenance of the Marketing Authorisation holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
The person selected to fulfil these duties should have knowledge and experience in working in pharmacovigilance, enabling them to implement and maintain a good pharmacovigilance system
The QPPV has a central role focused on ensuring the company is meeting all of its pharmacovigilance responsibilities and that ultimately the safety of the public using the medicine is maximised.
The PV Lead is responsible for management and oversight of the PV team and provision of pharmacovigilance services in accordance with Good Pharmacovigilance Practice for clients where applicable
Ensure a suitably organised and managed Pharmacovigilance team. Update and manage the company’s Pharmacovigilance systems in line with legal requirements. Identify propose, and implement practices for improvement.
Manage and oversee external PV Providers.
Review and update SOPs as required.
Ensure that information about all relevant suspected adverse reactions reported to the company and affiliates as defined in agreements, is collected, collated and is accessible within the PV system.
Oversee the maintenance of the PV system SOP’s and the associated PSMF.
Oversee and the tracking, completion of review of worldwide scientific literature on a weekly basis and ensure relevant information for reporting to Competent Authorities is reported in a timely manner.
Ensure all PSUR and medical variation applications are planned, tracked and obtained in a timely manner.
Track compliance of quality, completeness and timeliness for ICSR expedited and PSUR reporting requirements and safety data exchanges with partners.
Coordinate and ensure the allocation of Post Marketing Review Meeting (Signal Detection) responsibility, and provide input and oversight on an ongoing basis.
Facilitate third party and accreditation body audits; including contractors and PV service providers.
Maintain a program for audit pharmacovigilance system and Service Providers.
Liaise with the Regulatory Department to ensure label updates arising from Pharmacovigilance
activities are implemented.
Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012, dir 2001/83/EC, directive 2010/84/EU and UK Statutory Guidance, as applicable.
Fulfil the legal requirements of the Qualified Person role as defined in Eudralex Volume 9a, Dir 2001/83/EC, Reg 1235/2010, GVP Module I and UK Statutory Guidance as applicable. Fulfill the QPPV function for MAHs as listed in Appendix 2. Ensures QPPV has sufficient authority to recommend changes in the pharmacovigilance procedures to meet EU and UK requirements.
Development and oversight of the post Brexit UK PV system and how it links to the global PV system.
Ensure all key checks required by the QPPV are identified and completed in a timely manner.
Ensure that requests from the Competent Authority are tracked and answered appropriately.
Responsible for answering Medicines Information and Product Information queries and handling Adverse Drug Reaction reports.
The QPPV is responsible for ensuring that Company Sponsored post authorisation safety study (PASS) reports are properly assessed in terms of safety content and conclusion in the report. Implement clinical safety processes to support any new clinical studies if applicable.
Review and update PV agreements for all contractual arrangements and ensure reconciliations are carried out as outlined in the agreement.
Oversee the preparation of Risk Management Plans and risk minimisation activities, review and approve same.
Oversee the maintenance and update of the PSMF, review and approve same.
Ensure follow through the answering of referrals from the PRAC as applicable.
Act as central point of contact to the competent authorities on a 24 hour basis as the QPPV.
Act as the contact for the out of hours emergency medical information phone line.
Implement electronic reporting of ICSRs, populate the XeVMP using EudraVigilance and participate in completion as required and review.
Harmonise Pharmacovigilance global safety systems to ensure seamless communication with partners throughout Europe. This will include working with global marketing partners to ensure consistent collection and reporting of adverse event data to worldwide regulatory authorities.
Track and highlight updates to EMA and local drug legislation as it applies to EU and UK regulatory Pharmacovigilance requirements for investigational and post-marketing drug/biologic products.
Ensure compliance with pertinent GVP, GCP, GMP, ICH, international, and local regulations as well as adherence to SOP work instructions and guidance documents as they pertain to Pharmacovigilance practices in commercial marketing and clinical trials.
Optimise the use of resources at all times.
Ensure appropriate training for affiliates staff, contract research and safety organisations and clinical investigators with respect to safety systems and European Pharmacovigilance practices is in place. Provide Pharmacovigilance support and advice to relevant departments.
Make recommendations relating to general improvements of the business.
Attend external meetings/training courses to maintain/improve overall knowledge of Pharmacovigilance procedures, guidelines and directives.
Complete any other duties as considered necessary by the Company.
Ensure budgets are completed with justifications and adhered to following approval.
KPI and metrics reporting
OTHER SKILLS AND ABILITIES:
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