T: 905.363.1182 x.254
TF: 1.877.877.5152 x.254
2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Jackie is an enthusiastic and creative Healthcare Professional with extensive experience in the Pharmaceutical Industry. A proven specialist in Drug Safety & Surveillance; Risk Management & Risk Minimization Strategies. Represented the generic pharmaceutical industry in the ICH Expert Working Group together with Government leaders, health regulators, and other industry professionals to develop ICH Guideline E2D on post-market safety surveillance. She is a highly accountable team leader, acknowledged to be passionate about success and creating an environment of innovation and motivation with a will to achieve.
Skills & Highlights
Pharmacovigilance/Good Vigilance Practices (GVP)
- Developed Global Pharmacovigilance Compliance function for large pharmaceutical generics manufacturer. Developed process for Quality Management of Global PV systems to include self-audits and monthly QA and performance monitoring; developed Risk Management procedures to include signal detection, benefit-risk assessment, Risk management/minimization plan and maintenance & communication of risk & safety information.
- Provided strategic support to a corporate global Pharmacovigilance process, especially in the area of Risk Management programs through the product life-cycle (including pre-approval and post-approval).
- Ensured internal and external compliance of corporate and affiliate PV activities; providing strategic support and training and tracking compliance to the Pharmacovigilance process(es) of a large drug manufacturer and its affiliates and business partners worldwide.
- Served as member of corporate Medical Advisory Committee and Drug Safety Committee providing strategic insight in health-hazard classification, signal detection and data-mining techniques for risk assessment pre-and post-approval.
- Participated in restructure of a Global Pharmacovigilance unit into operational and compliance functions as member of the senior leadership team.
- Represented large drug manufacturer and participated in Industry groups, e.g., CGPA, IGPA as company liaison with local and international Health Regulators to establish guidelines and consult on regulatory matters involving PV topics. Participates in the expert working group for PV topics at ICH (EWG-E2D, E2F and E2C (R2)) representing the International Generic Pharmaceutical Association (IGPA). Represents CGPA in consultation with Health Canada on new Legislative Framework and PV Guidance.
- Managed recruitment, coaching and mentoring of staff. Developed strong performers in the team to assume leadership roles in a new corporate structure to include a Manager, PV, PV Project Leader and PV Associate roles.
- Championed pharmacovigilance support and raised the profile of pharmacovigilance within a large drug manufacturer, seeking executive support when required to create a separate department responsible for the global PV of generic products.
- Managed Drug Safety & Adverse Drug Event (ADE) function for Post-Marketing and Clinical SAE reporting - collection, assessment, coding, dissemination and regulatory reporting.
- Developed SOPs, training programs in ADR reporting for internal business partners in Medical Information, DRA, Clinical research, QA & Sales & Marketing; training of investigators (SAE) and sales reps (ADR).
- Participated in international Global Drug Safety System team, representing Canadian interests.
- Performed ADE reporting function on marketed products & SAEs on clinical trials.
- Served as medical Information specialist in CNS, Anti-Infective, Dermatology, HRT therapeutic areas; development of drug enquiry database; involved in a number of cross-functional teams responsible for new product launches.
- Performed mentoring, training & development of junior staff, PharmD & PMAC students.
- Conducted research into immunosuppressant therapy, vaccine vector, synthetic peptide for vaccine development.
- Realigned a Drug Information service to meet an expanding customer base in Quebec and the US and build a PV unit within Regulatory and Medical Affairs. Worked on a proposal to integrate Canadian and US customer service to develop a high performing team of customer service representatives skilled in triage of complaints and ADRs to the Quality and PV departments and capable of Drug Information intake.
- Managed the Drug Information Service and Post-Marketing Drug Safety Service within the Medical Information Division in Regulatory Affairs. Provided leadership and strategic planning in support of corporate vision - supporting Scientific Affairs functions, regulatory activities, as well as Domestic and International Sales and Marketing groups.
- Managed a corporate Special Access Programme in collaboration with TPD, Health Canada.
- Developed bilingual Drug Information Service: good verbal communication skills in French
- Conant, J. ICH Guidances and the impact on Drug Safety practices from an industry perspective, DIA Annual Canadian Meeting, November 2004.
- Conant, J. ICH- E2C Periodic Safety Reporting, Kusuri Conference, Ottawa, 2003
- Conat, J. Updates from ICH and the FDA – ICH E2D, -E2E, The Tome and beyond, Kusuri Conference, Ottawa, 2003
- Conant J. Integrating the Periodic Safety Update Review into your Drug Safety Program. IIR West Coast Annual ADR meeting, San Francisco Dec 3-5, 2001
- Conant, J, Sanhueza, S. Coping with the regulatory and workflow pitfalls surrounding licensing agreements while rising to the challenge of ADR reporting for co-marketed products. ADR 2001 Developing Best Practices Pharmacovigilance, January 22-23, 2001; London UK.
- Lee DHS, MacIntyre P, Wang E, Hudson D, Ishaque A, Conant J, Pope B, Lau C. A leukocyte lipid up-regulates the avidity of lymphocyte funtion-associated antigen-1. Biochem & Biophys Res Comm 1994, 199:319-326.
- Lau C, Wang E, Ishaque A, Jones K, Wong B, Kimsto L, Conant J. Spermine dialdehyde, a novel ex-vivo purging agent for both allogeneic and autologous bone marrow transplantations. Int J Immunopharmac 1992, 14:1081-1091.
- Kazmi SMI, Koop K, Li D, Conant J, Lau C. Role of aldehyde dehydrogenase in the biological activity of spermine dialdehyde, a novel immunosuppressive/purging agent. Pharmacol Res 1992, 25:1-10.
- Conant J, Kimsto L, Wang E, Lau C. Effect of spermine dialdehyde on ex-vivo purging of tumour cells in two autologous murine bone marrow transplant models. Blood, Nov 1990, (suppl):abstract
- Wang E, Conant J, Li D., et al. Ex vivo SDA treatment prevents lethal graft-versus-host
- disease in a murine bone marrow transplantation model. Bone Marrow Transplantation 1990,6:235-242.
- PhD studies (one year only), McMaster University, HAMILTON; Faculty of Medicine, Bill Rawls supervisor - viral oncology
- M.Sc., Medical Microbiology, London School of Hygiene & Tropical Medicine, University of London, LONDON, UK
- Certificate du langue française, Sorbonne, PARIS
- B.Sc. (Medical Laboratory Sciences), Faculty of Medicine, Department of Pathology, University of British Columbia, VANCOUVER, BC
- MLT (Medical Laboratory Technologist), Toronto Institute of Medical Technology (Michener Institute), TORONTO, ON
Continuing Education, Career Development
- Board Member, Mississauga-Halton Local Health Integration Network
- Retired Member Ontario College Medical Laboratory Technologist (CMLT-O), Canadian Society of Medical Laboratory Science (CSMLS)
- Represented the International Generic Pharmaceutical Association (IGPA) as industry observer at ICH expert working group (EWG) on PV topics. Participated in ICH-E2D, E2F guidelines and currently on EWG for ICH-E2C(R2) guideline.
- Faculty member of the Kusuri Canada Conference; Training course in ADR reporting based in Ottawa. Present on Risk Management Challenges for Industry (REMS, RMP-EU, ICH-E2E), PV Compliance, and PSUR reporting
- ARISg User Group, Oracle-AERS USER Group, MedDRA training, MSSO & Elliott Brown Training Ltd, April 2002, PharSafer EU Legislation training, 2012.
- Industry participant in the TPD Workshop – Dissemination of Safety Information (CGPA representative)