Manager - PV Compliance
|Job Title:||Manager - PV Compliance|
|Contact Name:||Alex Young|
|Job Published:||July 20, 2017 10:13|
Manager Pharmacovigilance Compliance & Safety Review, and Deputy LSO
- Lead the UK PhV Compliance team activities and act as line manager for the PhV Compliance and Safety Review team
- Act as the expert for Pharmacovigilance Team compliance issues, CCSI and Risk Management Plans. Act as back-up Pharmacovigilance Compliance/Safety Review Officer when required and have an oversight of all tasks carried out by the team.
- Continuously monitor and strengthen processes to ensure timely reconciliations, audits, training activities, SDEAs, CAPAs, CCSI and RMM.
- Maintenance, update and review of local controlled documents relating to Safety Review team responsibilities to ensure compliance with global/EU standards and to manage and co-ordinate process optimisation for the UK PhV Safety Review team as necessary
- To perform Company Core Safety Information and SmPC/PIL review, and support the review and implementation of UK National labelling changes.
- Ensure Compliance and Safety Review team members are fully supported, mentored, trained and encourage ongoing development
- Develop and/or utilise compliance monitoring outputs to appraise team on productivity/quality/compliance regularly
- Feedback team performance vs. KPIs to Director, UK PhV & LSO as applicable and via input to regular departmental meetings and reports demonstrating KPIs and key successes of team
- Ensure Compliance and Safety Review team objectives are assigned annually and reviewed during regular 1:2:1s to ensure delivery on time and according to the PhV Leadership Strategy
- As a member of the PhV Leadership Team provides ad hoc support to other team tasks upon request of Director, UK PhV & LSO
- Act as Deputy LSO ensuring LSO responsibilities undertaken in the absence of the LSO
- Support the Director, UK Pharmacovigilance & LSO as required to fulfil the role of UK LSO
- Ensure the annual PhV training plan for all UK employees is maintained according to global PhV requirements.
- Deliver pharmacovigilance training to all UK personnel, relating to responsibilities, regulations and procedures; to include delivery of basic initial training and additional specific training in pharmacovigilance aspects to specific types of personnel within the UK, as appropriate
- Ensure appropriate pharmacovigilance training is delivered to third party companies, service providers, contract research organisations and any other organisations contracted to us that could receive individual safety reports
- Ensure signed, dated job descriptions, CV, training records and organisational charts applicable to all UK PhV are in place and inspection ready.
- Participate voluntarily and as agreed with LSO in European projects and Working groups organised by Global Patient Safety or European PhV Management
- Maintain the Compliance team activity log
- Ad hoc support for ICSR and Safety Review teams as applicable and where agreed with Director, UK PhV & LSO
- Ensure compliance with all pharmacovigilance Global, European and Local SOPs and WIs; and where necessary review and perform gap analysis to ensure compliance with Global/European procedures
- Ensure knowledge of UK Legislative requirements with regards to Pharmacovigilance and compliance with all Local and European safety regulations, advising LSO of any changes to Local regulations in a timely manner
- Develop and maintain effective oversight strategies/metrics and appropriate outputs to monitor departmental compliance and KPIs and highlight concerns to UK LSO
- Responsible for ensuring all emails allocated to their team folder are actioned appropriately and in accordance with relevant procedures
- Ensure all Local and Global tracking systems related to UK PhV Compliance activities are updated on a regular basis
- Ensure appropriate recording and documentation of all processes and procedures that are subject to audit
- Manage and co-ordinate the initiation and implementation of process changes or improvements in UK pharmacovigilance system(s) to ensure compliance with corporate and regulatory requirements
- Perform the update and review of local controlled documents relating to Compliance team responsibilities to ensure compliance with global/EU standards
- Maintain the Local Business Contingency Plan for pharmacovigilance activities including maintenance of the list of appropriately trained back-ups for all LSO activities to ensure compliance during any absence
- Execute CAPAs related to Pharmacovigilance responsibilities as necessary in the event of deviations from SOPs/WIs, agreements or regulatory requirements and following internal audits, and inspections
- Manage to ensure that all required and appropriate Pharmacovigilance Agreements are in place and maintained with third party companies and other service providers, including market research vendors, clinical research organisations, third party companies and patient support program service providers.
- Perform final review of SDEAs before UK LSO approval and support the PhV Compliance Officer for the timely completion of the SDEAs and when issues have been identified
- Ensure reconciliation process is implemented and followed, support the PhV Compliance Officer for the timely completion of the reconciliation activity and advise on resolution of issues. If required, escalate issues and concerns to UK LSO.