Emma Webb Email & Phone Number

Princeton , Nj, Us

Additional responsibilities on top of PV Quality Systems Specialist role:• Establish and maintain the PV System Performance Report - work with internal Amicus teams (inc. GRA, QA, QMS) and external vendors to monitor KPI compliance and quality trends, to be presented to senior leadership and at governance meetings.• Manage Global Drug Safety, Affiliate and PV vendor training matrices. Co-ordinate role profile impact assessment following new or updated procedural changes, identify and train relevant staff on these procedures.• Develop Business Continuity Plan (BCP) for critical PV functions and annual test scenario protocols - test, evaluate results and implement necessary CAPA plans.

Princeton , Nj, Us

• Coordination and management of EU & UK PSMF and Summary of PV System. Support affiliate teams with the preparation of local PSMF/ PV System Sub-file requirements.• PV-SOP management (Global and Affiliate QMS documents).• Trackwise ‘super-user’ - Functional CAPA coordination, trending and tracking. Accountable for CAPA evidence gathering and CAPA reporting to GDS leadership and compliance committees. • MasterControl 'super-user' - Maintaining the QMS; creating and maintaining SOPs and Working Instructions for global processes and requirements.• Monitor emerging PV reg intel and update GDS leadership/ functional SMEs on the ramifications of regulatory changes and impact of compliance risk on current processes.• Support inspection readiness activities and provide operational support during internal process audits/ external regulatory inspections.• Represent GDS on cross-functional projects and initiatives as directed by GDS leadership.

Boulogne Billancourt, Fr

Leadership in defining and implementing departmental strategies and procedures to align with company visions and goals. • Audits and Inspections:o Primary source of subject-matter expertise in audit and inspection interviews.o Propose and implement CAPAs following audits and inspections.• PV Systems:o Maintaining the QMS; creating and maintaining SOPs and Working Instructions for local processes and requirements.o Creating template forms, letters and emails for upload into the MI Database (IRMS), subsequent content management of this database.o Creating and implementing CAPAs and deviations in accordance with procedures.o Validating PV systems initially and changes over time, documenting and uploading such that is it available on request.• PV 3rd Party Vendors:o Oversee compliance of vendors with internal company requirements, point of contact for vendors to set-up and lead compliance meetings. Working together to develop processes to resolve noncomplianceo Creating and updating contracts/agreements in co-ordination with LPMo Act as the safety expert for Ipsen projects, including early access and market research programmes• ICSR Case Processing:o Monitoring and triage of the Medical Information and Pharmacovigilance mailboxo Data entry to the Medical Information database, forwarding of ICSRs to Global PV, creation and distribution of follow up letters, case closure, Quality Check (QC) of colleagues data entryo Reconciliation of monthly line listings from Ipsen projects o Literature review for adverse events and other experiences involving Ipsen products and subsequent completion and maintenance of the appropriate documentation.• Extrapolation and statistical analysis clinical trial, literature and post-marketing data for submission to National Institute for Clinical Excellence (NICE).• Interviewing potential candidates for PV Associate and PV Manager roles in co-ordination with the RSQ Director

Ballerup, Dk, Dk

• ICSR case Processing • Sole responsibility for creation, development and delivery of all PV training for staff and external suppliers including streamlining project, creating multiple product specific training videos for all staff and external suppliers. • Maintenance of the LEO Pharma Quality Management System (QMS) • Administrative support in relation to Medical Information enquiries and enquiry escalations.• Test calls and QC of reports received from Medical Information• Reconciliation of monthly line listings from Medical Information, Patient Support Programmes and Market Research Projects, tracking of Suspected Unexpected Serious Adverse Reaction (SUSAR) line listings from clinical trials.• Literature review for adverse events and other experiences involving LEO products and subsequent completion and maintenance of the appropriate documentation.• Oversight and maintenance of PV archiving including collaboration with the outsourced archive company and maintaining a record of all information held off-site.• Assisting the UK/IE PV Executive in audits and inspections, ensure audit findings are actioned and evaluated in accordance with procedure. • Took over processing, management and reconciliation of Product Complaints• Direct consultation with patients and Healthcare Professionals (HCPs), manufacturing sites, including securing complaint sample availability, arranging couriers for collection of samples, organising delivery of replacements, summarising investigation closure reports and communicating the findings to stakeholders. • Proposed and produced monthly PV One Minute Mail and Medical Division Newsletter• Reaching out to HCPs and guest speakers for International Group Conferences, arrange department specific activities, entertainment and food.• Member of steering committees such as the Onboarding Focus Group

As well as giving me an understanding of the business at both a local and national level, this position has rewarded me for commitment, reliability and good decision making. In addition to providing excellent customer service on shift, my main responsibility is to ensure the smooth running of the pub in my manager’s absence, this includes practical tasks such as data collection and input into excel spreadsheets, ordering and maintaining stock, organising bookings and arranging meetings with both area and regional managers as well as training and coaching team members, overseeing their progress and giving feedback.

Setting standards of service, behaviour and presentation. Motivating, directing and training fellow team members.

Bachelor'S Degree, Biomedical Sciences

Master Of Science - Ms, Psychology