Lisa Chan's Email Addresses & Phone Numbers

📖 Summary

Senior Director for Global Safety and Pharmacovigilance @ From November 2015 to Present (2 months) Head of Global Pharmacovigilance @ Key responsibilities: Global responsibilities for pharmacovigilance operations for Besins Healthcare’s products. Ensuring quality standards are in place and maintained for pharmacovigilance processes such as regulatory report of ICSRs, PSURs, to licensing partners, standardisation execution of SDE agreements, creation of pharmacovigilance SOPs, guidance and policy documents, signal detection, labelling of company safety documents and literature searches and reviews. Ensuring Besins Pharmacovigilance is operating in compliance with EU and worldwide regulations to ensure the safety of patients taking Besins products. Chairing Global Safety Committee meetings and a Global Labelling Committee member to have worldwide oversight of the safety of Besins products. Ensuring training systems are in place to ensure personnel are appropriately trained to perform their job functions. Management of the Global Pharmacovigilance Operations with the assistance of the EU QPPV and Deputy QPPV and liaising with Medical Affairs, Medical Scientific Affairs, Regulatory Affairs, Business Development, Corporate Development, Legal Affairs and Product Quality Management Department. Raising global pharmacovigilance awareness to Besins personnel. From November 2011 to November 2015 (4 years 1 month) Senior Manager, Pharmacovigilance, Europe @ Key responsibilities: leading European offices in Edinburgh and Slough, totalling 18 members of staff, ranging from Senior PV officers to entry levels. Streamlining processes and procedures and ensuring adherence to Global SOPs by the team. Additional responsibilities include yearly budget forecasts and predictions, payroll, ensuring adequate resources are allocated to the studies and study teams, primary contact for clients for escalation processes. Budget and proposal reviews on a global level, attending bid defences and building client contacts and confidence in Chiltern’s Pharmacovigilance Services. Meeting clients to discuss their Pharmacovigilance service requirements. Assisting with audit and regulatory inspections, ensuring the Pharmacovigilance team is at an inspection readiness level at all times. Supporting US PV team with process improvement, reviewing study budgets, time allocation, training of EU regulations and supporting with audits from US clients. I was also responsible for the progression and the development of the team, ensuring each member of the team is adequately trained to perform within their job role but also encourage positive working practices and ethics. From May 2008 to November 2011 (3 years 7 months) Slough, United KingdomDrug Safety Case Manager and UK Affiliate @ Daily triaging, performing duplicate searches, booking in of all adverse event reports received by the company as per company SOPs and regulations Conducting follow up as required with healthcare professionals and consumers Data entry of spontaneous, device and clinical trial reports into ARGUS, peer QC of reports and providing constructive feedback to colleagues Working with the sales team and providing support and guidance to individuals not performing their AE reporting requirements as per company SOPs Key contact person for the Medical Information Department for reconciliation of AE reports, providing support and guidance to individuals, co-ordinating training programs Key contact and coordinator in the development and pilot testing of the affiliate adverse event tracking tool, global lead contact for the tool, development of a training plan for this tool Expediting and submitting reports to ethics committees, keeping to reporting deadlines, generating and scheduling reports, updating relevant databases Performing workflow management activities, escalating significant compliance issues to management, notifying power users of any system issues From January 2007 to April 2008 (1 year 4 months) Drug Safety Associate @ Lead DSA for multiple studies and responsible for training CRA’s on Pharmacovigilance responsibilities and mentoring new starters in PV Therapeutic Area Experience • Diabetic retinopathy • Hepatitis C • Oncology • Central Nervous System Key areas of Responsibility: • Lead DSA for several projects in the following therapeutic areas: o Diabetic retinopathy o Hepatitis C o Oncology • Countries of origin included South Africa, Israel, UK, ROI and EU countries • Ensuring on time reporting to clients of serious adverse reactions according to study specific procedures • Taking part in reconciliation for a global study over 50 sites and completed within the deadline. • Training entry level DSA’s on SAE reporting and responsibilities according to study specific procedures • Attend study close out meeting with Sponsor’s and CRA’s, highlighting PV issues requiring resolution to meet database lock timelines. • Writing study specific procedures according to client requirements and contracted responsibilities in pharmacovigilance From April 2005 to December 2006 (1 year 9 months) Southampton, United KingdomStudy Supervisor @ From April 2004 to April 2005 (1 year 1 month) MSc, Toxicology @ University of Birmingham From 2001 to 2002 BSc (Hons), Biomedical Science @ Liverpool John Moores University From 1998 to 2001 EV Lisa Chan is skilled in: CRO, Pharmaceutical Industry, Pharmacovigilance, Patient Safety, Drug Safety, Department Budgeting, Revenue Recognition, Partner Management, Process Improvement, Close Attention to Detail, Goal Oriented, MedDRA, E2B, ARISg, SAE Reconciliation