Purpose of Role
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.
- 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.
Skills and Experience (E: Essential, D: Desirable)
- Min 3- 5 years of experience in Pharmacovigilance/Drug Safety/Medical Information within a commercial Pharmaceutical Environment (E)
- Demonstrable Expert knowledge in EU and UK PV legislation (E)
- Experience in regulatory agency inspection planning, preparation, conduct, management and agency interactions (E)
- You are used to work in a multidisciplinary team and have strong planning organisational skills (E)
- Strong communications skills both written and verbal (E)
- Strong Customer Service focus both internally and externally (E)
Please contact Liam Smith on 01925 90943 or