Rosalind Sackey

Accomplished Pharmacovigilance professional, passionate about Drug Safety, with over 15 years of industry experience with Major Pharmaceutical corporations and MHRA. Solid experience in the complete range of Pharmacovigilance processes ranging from ICSR, data entry and analysis/authoring of medical safety documents development, Medical Information Provision, implementation of Standard Operating Procedures and Corrective Action Plans. Good knowledge of European and international pharmacovigilance regulations, GVP Guidelines, Good Clinical Practice, ABPI, Clinical Trial Regulations, Good Distribution Practice.

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.

MSc - Analytical Chemistry - Birkbeck College

B.Sc. (Hons) - Applied Chemistry - University of Greenwich

Diploma - Industrial Studies