Othniel Danat (Bpharm, Msc) Email & Phone Number

Hemel Hempstead, Gb

County Dublin, Ireland

• Provide support and oversight to outsourcing partners to facilitate compliance with regulatory and legal requirements.• Manage external relationships essential to delivering PV and regulatory responsibilities. • Effective planning of report to ensure that stakeholder input is requested/received for applicable sections of pharmacovigilance reports to meet regulatory reporting deadlines. • Contributes to relevant sections of pharmacovigilance safety reports in collaboration with the safety physician. • Responsible for supporting the management and oversight of pharmacovigilance audits, inspections, and related performance improvements, applicable to PTC Regions and the Pharmacovigilance Affiliate & distributor network. • Drive the enhancement of existing process and partnerships through knowledge of internal and external environment. • Provides and ensures oversight for the technical and scientific support for safety surveillance and signal detection activities for PTC products. • Work with the relevant personnel across PV, partnership, patient safety and regulatory to develop, monitor and report on global KPIs related to safety and regulatory data. • Collaborates with key stakeholders outside of PV. Represents the PV department in cross-functional clinical program teams, providing support to development programs • Collaborates with medical monitor(s), safety physician and Regulatory Affairs to monitor that expedited safety reports to appropriate domestic and international regulatory authorities is conducted within required timelines. • Utilise knowledge to maintain and support the global inspection readiness strategy. • Participates in and, as necessary, actively contributes to, investigator meetings. • Interfaces with medical monitors for medical assessment and regulatory classification of SAEs; manages and facilitates SAE reconciliation across projects.• Serious adverse event follow-up and case closure & execution of reconciliation.

Cambridge, England, United Kingdom

Introduction: The Patient Safety Vendor Support Manager assists with oversight of contractor and vendor performance and deliverables, and reports to the Sr. Director Patient Safety/Vendor Resource Manager in the Vaccine Program. The role entails assistance with oversight of activities and people in the Patient Safety Vaccine Program, as this relates to 5 workstreams: Clinical Trials, Safety Surveillance and Signal Detection, Submissions and Related Queries, Document Support/RMP, and Postmarketing Health Authority Queries and Regulatory Questions. Main Responsibilities:• Meets with contractors and vendors to ensure timely oversight of high quality deliverables• Leverages Patient Safety expertise and knowledge of PV regulations to assist with planning and delivery of documents and tasks under tight timelines• Provides detailed information to the Vendor Resource Manager and Project Coordinator to ensure issues are addressed • Attends team meetings and maintains a line of sight of key PV issues and deliverable timelines• Provides strategic leadership with resourcing and onboarding activities• Assists with all aspects of onboarding of new team members

London, England, United Kingdom

• Reviewing/providing input to the annual Audit Plan in close collaboration with Regional Heads & Safety Officers · • Clinical and post-marketing PV process optimization including SOPs and data entry guidelines.• Oversight of PV vendors.• Support vendor process development and process review. • Participate in project and clinical team meetings for assigned projects. • Providing operational support as required with audit preparation activities, front and back-room support, audit response and close out of audit CAPA commitments, to ensure consistency and alignment with local and global requirements · • Tracking and trending of audit findings related to Regions/Affiliate activities and recommending process improvements to prevent recurrence. · • Supporting Affiliates in Process Assessments, as and when required Support the process for responding to safety questions from regulatory authorities.• Review of medical and scientific literature for safety information.• Support SAE reconciliation.

Darmstadt Area, Germany

• Support TMF activities for company sponsored oncology phase I to IV studies.• Participate in other risk management activities.• Review of safety sections of study related documents (e.g. Clinical Trial Protocol, Drug Safety Manual/Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan, Trial Oversight Plan) including documents for Investigator Sponsored studies, Communication of clinical studies within Global Patient Safety (e.g. clinical study status). • Prepare and deliver presentations at safety team meetings; participate in clinical study team meetings as appropriate.• Contribute to defining and implementing of clinical trial safety related activities in the alliance with relevant partners’/service providers of Merck and alignment of guidelines and processes related to clinical trial safety management with existing Global Patient Safety processes, Support post-Marketing activities (e.g. Global Literature Surveillance).• Assist with Responding to health authority or other queries & Support labelling changes as appropriate.• Review of safety sections of informed consent form.

Galashiels, United Kingdom

• Work performed by the vendors is conducted on time and to high quality including the correct classification of individual case report. • The relationship between the vendor and Kyowa Kirin is cooperative and synergistic rather than transactional. • The contracts are managed in a proactive manner such that there are no crises at the vendor or at Kyowa Kirin.• Through the monitoring of specific and agreed metrics, the vendor meets its targets such that Kyowa Kirin is compliant with required regulations and the meeting of company objectives. • Kyowa Kirin provide to the vendor all required technical information to perform its activities in a timely manner and to required quality. • Kyowa Kirin proactively provide future workload estimates to enable the vendor to be sufficiently resourced to meet company objectives. • To negotiate safety collaboration agreements to ensure relationships with Kyowa Kirin’s business partners are conducted within a framework to ensure compliance and to monitor such agreements to ensure a smooth, collaborative working relationship. • Pharmacovigilance activities integral to cross functional projects being performed by vendors contracted by other functions are performed on time and to quality. • To work cross functionally within project teams to meet Company objectives and to represent the Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team. • Any other activity that may reasonably be required from time to time

Slough, United Kingdom

• Maintaining the PV Quality Management System and quality related activities• Responsible for training, development of junior PV personnel• Coding of Medical Terms and medicinal products• Safety data management from different sources including spontaneous, literature and national health authority sources• Support Business Development efforts with new and revised projects. • Review safety data in the Global safety database• Oversee development of project-specific Pharmacovigilance budgets and proposals • Contribute to development and maintenance of Pharmacovigilance System Master File (PSMF)• Oversee development of project-specific Pharmacovigilance budgets and proposals • Knowledge of ARGUS previously worked with ArisG• Management of case data for Eudravigilance submission• Review of safety information published in scientific literature • Fulfil the following responsibilities within a designated geographic region: oversee workload, timelines, audit readiness, oversee departmental implementation of department procedures; and ensure procedures meet regulatory requirements; ensure 24/7 coverage for the department • Review and maintenance of effective Safety Data Exchange Agreements between sponsor and its business partners • Ensure timely escalation of departmental and project issues within Chiltern and to the Sponsor, as needed, to support subject safety • Implement and monitor compliance metrics to ensure regulations and timelines are being met for both expedited and periodic reporting • Develop and implement procedures to ensure Pharmacovigilance files are properly maintained and / or provided to Records Management in a timely manner • Develop and implement procedures to ensure corrective and preventive actions (CAPAs) are provided and closed in a timely manner for audits and inspections performed within the region• Manage fourteen direct reports • Perform other duties as required by the Department.

Horsham, Uk

• Knowledge of ArisG• Budget control for assigned projects as required • Act as a point of contact for National Competent Authorities / Ethics Committees • Screen adverse event reports received and categorise reports within safety intake systems • Evaluate and process ICSRs (Individual Case Study Reports) including duplicate checking, MedDRA coding, narrative writing, and tracking • Oversee the maintenance of the safety mailbox • Perform quality control and provide feedback on ICSRs • Generate data listings from the safety database • Correspond with Health Care Professionals regarding adverse events in both writing and by telephone • Maintain safety filing and archiving system • Preparation and maintenance of project specific documents, addendums, working instructions and other procedural documents as required for the project • Creation and quality control of periodic safety reports and the accurate distribution of such reports and urgent safety correspondence to National Competent Authorities, Ethics Committees and Investigators • Set-up, validation and maintenance of a project specific safety database • Registration with Eudravigilance and other National Competent Authorities as required • Liaise with data management groups for SAE reconciliation • Maintain an excellent awareness of current and potential guidelines/legislation on Pharmacovigilance and related matters, clinical trial guidelines and other relevant topics • Participate in internal and external audits and inspections by National Competent Authorities • Development and execution of training programs for personnel • Mentor new safety scientists • Perform searches of safety database and other relevant electronic tools, using scientific interpretation skills to assess the data and produce reports • Ensure compliance with local and international safety regulations and procedures • Write Standard Operating Procedures (SOPs) relevant to Pharmacovigilance/Safety

• Gather information or assign tasks or activities for a given project with minimal direction. Acts as project lead• Mentor, and manage direct reports, with responsibility for employee performance evaluations; mentors junior staff to ensure competence in pharmacovigilance skills and knowledge; translates overall direction and strategy, communicates across organizational levels and functions; interprets and executes policies and procedures, and provides direction based on general policies and management guidance• Plan effectively to receive, deliver, trend or produce performance metrics reports or data in a timely manner• Plan the corporate annual events which included team building-based training initiatives• Establishes work priorities with minimal direction from manager• Delivers a preliminary analysis of data for performance metrics or reconciliation activities• Delivers the final analysis of performance metrics or reconciliation reports• Works with internal or external third parties in the areas of performance metrics, to clarify any data inconsistencies or trends• Participates in business continuity records management and DSPH record retention reviews• Participates in audit and inspection support • Reviews new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation• Works with applicable teams within DSPH or in other functions to implement and maintain activities or tasks under the remit of S&C• Recognizes the need for and seeks assistance from appropriate internal and external resources for projects with ability to recommend or clarify requirements/solutions or escalate concerns to Sr. Management• Highlights areas of concern to manager; able to make recommendations for improvement• Provides regular updates to manager, including challenges and suggested actions that could be taken• Maintain confidentiality (especially on patient records), with good attention to det

• Ensure timely reporting of SAEs to Competent Authorities and partners• Ensure planning and distribution of the periodic safety reports (DSUR, PSUR, 6 monthly line listings)• Monitor compliance metrics and ensure appropriate documentation when deficient• Prepare and communicate compliance reports (monthly, Quarterly and yearly)• Prepare procedures, SOPs, guidelines and other standard documents for projects • Participate in Quality Control activities of cases from clinical development and post-marketing• Maintain an in-depth knowledge of the relevant drug safety software• Attend, participate to team meetings• Keep informed about regulations, legislation, ensure compliance with ICH, EMEA and FDA guidelines• Coordinate dissemination of specific regulatory intelligence• Record and communicate global regulatory requirements• Support the preparation of proposals• Participate in relevant seminars and congresses• Ensure overall compliance with ICH, EMEA and FDA guidelines• Other duties as assigned by management

* Management of the GPV mailbox. * Process and expedite single case reports according to GPV standards and timelines. * Manage Ovid alerts and assist in reviewing and monitoring of medical and scientific literature relevant to the safety profile of Norgine products. * Provide support for internal audits and regulatory inspections as appropriate * Assist in preparation and/or authoring of PSURs and signal detection reports. * Ensure the terms of SDEAs are followed where appropriate and that any specific SDEA requirements are met. * Ensure regular reconciliation of ICSRs between GPV and Medical Units and partner companies * Provide input into the development and update of processes including the development of SOPs and other procedural documentation

Guildford, United Kingdom

* Data Entry onto company validated database (ARISg web based & Clintrace) * Data review on Company validated database (ARISg web based & Clintrace) * Review of safety information from clinical trials and post marketed products * Global electronic reporting of safety cases to Regulatory Agencies & client partners * EVWEB submissions * Global paper reporting of ADRs to Regulatory Agencies * Compliance matrices for client and Company review * Literature searching for ADRs, SSR &PSUR * Coding adverse events including MedDRA coding * Helping with producing summary safety tables for client review * Preparation and training for Regulatory Inspections & audits * Follow up of safety cases to closure * Tracking cases. * Safety email In-boxing & triaging cases * Adverse event cases file productions and archiving * Understanding and helping with determining ADR reportability * Attendance at meetings concerning possible client work * Answering medical information enquiries * Filling of cases and source documentation

• Causality assessment & narrative writing• Case processing in pre/post-marketing pharmacovigilance• Data entry, data review, coding using MedDRA & safety reporting• Literature searching• Compliance monitoring & case follow up• Assessment for follow up items or missing information• Reference documents/labelling/expected assessment

Master Of Science (Msc), International Public Health/International Health &Management

Courses include health services and public health research, health economics, public health, applied statistics, epidemiology, managing.

Bachelor Of Pharmacy (Bpharm), Pharmacy