Head of Pharmacovigilance - MAC Clinical Research
(2020-11 - 2023-12)
Implementation, management and leading the Pharmacovigilance Department, provision of expert Pharmacovigilance Support to MAC Clinical Research and its customers.
- Provide leadership to the Pharmacovigilance department and the Pharmacovigilance team assigned to individual projects.
- Oversee the Pharmacovigilance department to ensure delivery of high quality deliverables, on time and in-line with customer expectations to achieve a high level of customer satisfaction.
- Lead PV focused project team meetings, meeting frequently with the project team to ensure that all deliverables are planned and coordinated within the project team.
- Work with the project team to proactively identify potential risks and put in place mitigation and contingency plans.
- Effectively communicate any data-driven discussions to achieve project deliverables on time and to high quality.
- Serve as the Pharmacovigilance Lead for allocated projects.
- Responsibility and accountability for all PV deliverables per the agreed project timeline.
- Provision of leadership to the PV project team and instruction and guidance to deliver the project objectives.
- Review the project team's output regularly to ensure the highest quality deliverables.
- Review and, where necessary, adjust the resource allocation within the PV department to ensure that the PV project portfolio can be delivered effectively, on time, within budget and to a high quality.
- Ensure that all relevant protocols, project plans, SOP's and regulatory requirements are adhered to.
- Develop timelines with the Project Manager for all PV deliverables, in line with the project contract and overall project/business objectives.
- Communicate risks and issues effectively to the project team and provide regular updates on PV deliverables to the project team.
- Ensure that all Pharmacovigilance documentation is generated in a timely fashion in accordance with SOP and project timelines.
- Maintain complete and accurate records for all PV activities.
- Generate, review and provide input into project plans and project documentation.
- Develop and drive best working practices and process to support all activities within the PV department. Input in writing, reviewing and updated departmental SOPs and associated forms and templates.
- Perform PV tasks including, but not limited to; DSURs, SDEAs, Training requirements of PV department.
- Assist with further training development of PV within the company by keeping up to date with Clinical Trial developments and regulatory changes.
Qualified Person Responsible for Pharmacovigilance (QPPV) - Sigma Pharmaceuticals
(2019-08 - 2020-11)
Provision of Compliance Metrics for assigned business processes to support continuous process improvement and organisational evolution, driving timely measurable and actionable feedback for proactive change.
- Performance of quality review of compliance data. Utilisation of expertise of AE reporting and analysis to develop/enhance the identification and investigation of causal candidates precipitating from root cause.
- Review of Deviations and Non-Conformances, Change Controls, Corrective and Preventative Actions (CAPAs).
- Assess timelines of risk management processes in accordance with relevant guidelines and internal standards.
- Author new SOPs and Work instructions for assigned processes to ensure all procedures utilised are documented in accordance with regulations and internal requirements.
- Responsibility for negotiation, coordination, end to end evaluation and delivery of Safety Data Exchange Agreements (SDEAs) with Licensing Partners.
- Development and maintenance of SDEA templates, implementation and change management activities to ensure legal regulatory legislation updates, in relation to drug safety and vigilance.
- Provision of monthly service reports, Review of ICSR process and reports, Review of collating all adverse reports from various sources including ASPRs, Literature Search and Spontaneous reports.
- Change of Ownership associated Pharmacovigilance activities, SIGPV database design and optimization activities.
- Advising on and generation of Pharmacovigilance SOPs, Reviewing and approving new and updated SOPs.
- Review and approval of annual product safety reports and PSURs and RMPs.
- Identification of product safety issues arising from annual product reports and PSURs.
- Handling Regulatory Authority Requests and RMP RFIs.
- Provision of recommendation of action to be taken by the Company.
- Provision of training and support to Pharmacovigilance Staff (inclusive of Sigma Site Wide PV Training).
- Review and provision of Medical Information in accordance with ABPI.
- Assessment of queries and enquiries and performance of updates of FAQs.
- Signatory for Marketing Dept New Product Launches, ensuring medical accuracy and integrity.
- Audit of the Company's Pharmacovigilance system and attendance and participation in inspections by competent authorities.
- Attendance at Signal Detection Meetings.
- Provision of PV Activities for other specified MAHs.
- XEVMPD new licenses population in EudraVigilance.
- Implementation of European Medicines Agencies (EMA) Pharmacovigilance related legislation and updates.
- Implementation of decisions taken at regular meetings held with the Quality Assurance Team.
Senior Pharmacovigilance Officer / Deputy QPPV - Sigma Pharmaceuticals
(2016-03 - 2019-07)
Responsible for the establishment of a functioning Pharmacovigilance Department at Sigma Pharmaceuticals.
- Deputise for delegated EU QPPV duties during absence of the QPPV.
- Deputy QPPV is briefed about current product safety issues and access to the necessary documents is ensured.
- Overview of safety profile of products marketed in EU.
- Provide input to preparation of regulatory action in response to emerging safety concerns.
- Support prompt response to questions from competent authorities.
- Communication and coordination across QPPV supporting functions.
- Review of PV compliance data with support for corrective and preventive actions.
- Oversight of the processes and standards for products under development from an EU legislation perspective, including recommendations for improvement.
- Support any QPPV activities as required in compliance with (GVP Guidelines) Good Pharmacovigilance Practice and all other relevant internal and external regulations and standards.
- Continuously provide to and retrieve from the EU QPPV all relevant information related to responsibilities and the QPPV function, for example; product safety profiles and issues, health authority interactions, processes and standards for global PV System, compliance status including corrective and preventive actions, internal and external partners and improvement projects.
- Provide scientific support to the QPPV function, acting as senior expert in PV processes and standards.
