Stephanie Haynes Email & Phone Number

Sydney, Australia

• Support the management of drug safety operational processes at Australian affiliate to ensure compliance with Novartis procedures, and national and international regulations for pharmacovigilance of Novartis marketed and investigational products within Australia and New Zealand territories• Manage the collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for Novartis products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, and commercial programmes• Ensure recording and tracking of receipts, submissions and distributions of Serious Adverse Events (SAEs), SRs and Periodic Safety Update Reports (PSURs)• Manage reporting/submission/distribution of safety reports/updates and information to local health authorities and/or clinical operations• Ensure timely preparation and submission of KPI reports on AE reporting including identification of root cause(s) for late reporting to local health authorities, development and implementation of corrective action(s) as needed• Provide training to local associates on relevant drug safety procedures for AE reporting and ensure training of clinical trial study personnel on Novartis drug safety procedures and guidelines for SAE reporting• Responsibility for the review of clinical study concept sheets and protocols for local and third-party studies

London, United Kingdom

In addition to the responsibilities outlined for the Senior Drug Safety Officer/Drug Safety Officer profiles below: • Overall responsibility for the production, distribution, timely submission and tracking of Periodic Safety Update Reports, Annual Safety Reports and 6-monthly line-listings to relevant worldwide regulatory authorities and ethics committees• Lead role in maintaining the worldwide regulatory reporting requirements for submission of safety reports associated with the company’s marketed and investigational products• Responsibility for the preparation, review and update of Safety Standard Operating Procedures and Work Instructions• Supervise regular internal case processing meetings to develop process improvement initiatives and optimise MPE safety reporting procedures within the department• Pivotal role in preparation for MHRA PV inspection and interviewee, in addition to an inspection readiness audit carried out by an external consultancy company• Line manager to two direct reports including organising regular 1:1 meetings and carrying out annual performance reviews. Additionally, assist with interviewing for new team members• Deputise Senior Manager, Safety, as required

London, United Kingdom

In addition to the responsibilities outlined for the Drug Safety Officer profile below:• Lead Safety Officer for drug development projects (Phases I – III), attending bid defence meetings, regular project team meetings and maintaining effective working relationships with internal departments and external vendors• Pivotal role in reviewing study protocols and authoring study-specific Safety Monitoring Plans• Involvement in SAE data reconciliation, and QC and review of Clinical Study Reports• Provide training for new associates at the company and at Investigator Meetings on MPE safety reporting procedures• Act as Aris Local Support Co-ordinator and assist the Aris Local Administrator in maintaining the Aris local system, including attendance at annual international Aris Global Safety Users’ Conferences• Involvement in preparation for MHRA GCP inspection and interviewee

London, United Kingdom

• Responsibility for monitoring the case process flow within the Safety group to ensure that the collection, safety review, internal reporting and dissemination of all adverse event reports is carried out efficiently• Key role in ensuring that internal and external reporting timelines are met and that worldwide regulatory authorities are notified as required by local regulations• Liaise with Japanese & US and CRO Safety departments regarding SAE reporting procedures and issues• Overall responsibility for the compilation and presentation of the company’s safety compliance metrics at monthly departmental meetings• Assist in the maintenance and upgrade of the global safety database (ARISg) and the E2B report tool

Guildford, United Kingdom

• Triage, assess and process local spontaneous and literature adverse event reports ensuring timely reporting to the global Pharmacovigilance office for the company’s Central Nervous System and generics products (Winthrop Pharmaceutical UK Ltd) • Assess UK and worldwide CIOMs to ensure correct reporting of adverse events to regulatory authorities, as required• Key role in authoring and submission of PSURs and Bridging Reports as required by UK affiliate• Preparation of both verbal and written responses to ad-hoc safety enquiries received from Healthcare Professionals and consumers • Lead responsibility for assessing and processing Product Technical Complaints for the company’s Central Nervous System products• Involvement in local signal detection, including communication with the global Pharmacovigilance office regarding identified potential signals • Deputise team leader, as required

• Record serious adverse event (SAE) details onto the global safety database (Argus Safety) within agreed regulatory timeframes for Clinical Trial, Post-marketing and Registry cases• Use thesauri and working practice documents to code medical history, drugs and adverse event terms. Prepare event narratives summarizing the essential details of the case. Assess each report to determine the necessity for follow-up and prepare follow-up requests as needed• Work closely with Clinical Safety Scientists and Medical Safety Experts to ensure accurate reporting of adverse event reports• Assist with the training on data entry procedures and working practice policies, and mentoring new starters within the department• Pivotal role in developing a process improvement initiative to harmonise the follow-up request procedure within the department