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.

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.
• 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

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.

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.
• 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.
• Assist with Responding to health authority or other queries & Support labelling changes as appropriate.

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.

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

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

• 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.
• 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

• 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

* 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.

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.

• 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

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