Dr.

LIOUDMILA RODIONOVA, PH.D.

*** *** *****, ***.#7-450-***-****

Laval, Qc, H7N 1B5 *********.*********@*****.***

SUMMARY

Languages: English, French, Russian.

Experienced Case Manager in Drug Safety Surveillance with demonstrated abilities in evaluating and processing adverse events and addressing safety-related inquiries. Extensive knowledge of reporting regulations for adverse events in the United States, Canada and Europe. Eleven years of experience within a biopharmaceutical company. Solid understanding of GCP and ICH guidelines, strong academic background, exposure to multiple therapeutic areas, experienced people and project manager.

EMPLOYMENT HISTORY

AEGERA THERAPEUTICS INC. Nun’s Island, Montreal, Feb-2009 – Jul-2010

Manager, Drug Safety/ Pharmacovigilance

Main responsibilities: start up and develop drug safety/pharmacovigilance department (set up in house safety database, SOP, internal and external procedures for pharmacovigilance activities, including SAE processing and analysis of safety signals), develop Safety Management Plans, update and submit Investigator Brochure, review of CSRs. Prepare and submit expedited reports and annual updates to Health Canada, EMEA, FDA (through i3CanReg), BfArM (Germany) and DoH (Hong Kong). Answer regulatory agencies inquiries

• Successfully transferred major safety responsibilities from CRO to Aegera Therapeutics Inc.

• Developed internal SOPs and procedure and started pharmacovigilance department

• Successful audit of the pharmacovigilance department

• Lead a closure from a safety point of view of completed studies on Acute Myeloid Leukemia, Pancreatic, Breast Cancer and Non-Small Cell Lung Cancer

• Received EMEA certificate to repot ICSR in EEA

BELLUS HEALTH Inc (NEUROCHEM Inc), Laval, Canada Oct-2001 – Jan-2009

Manager, Drug Safety/ Pharmacovigilance, Strategic Planning & Scientific Affairs (Apr-2005 to Jan- 2009)

Main responsibilities: develop and maintain professional relationships with principal investigators, prepare documents for DSMBs meetings, write and review medically-accurate narratives, expedited reports (ARGUS Database) and safety sections of regulatory, clinical and medical reports in compliance with drug safety regulations and ICH guidelines, review codes of medical terms and medical conditions in safety reports using MedDRA, provide guidance and training to internal, clinical, regulatory affairs and CRO personnel, interact and communicate with external vendors, manage internal budget, lead compassionate use program, review medical scientific literature, work closely with investigators in safety reports closure and reconciliation with clinical database.

• Constantly provided effective training and support in daily activities to CROs, clinical sites and members of Pharmacovigilance, Regulatory and Clinical departments by responding to requests, aid in answering questions and filling SAE reports.

• Succeeded in closure of SAE cases, preparation for reconciliation with clinical database and on time locking of the safety database for North American open label study, European double blinded placebo control study on Alzhemed (Alzheimer disease, CNS) and open label study on Fibrillex (secondary amyloidosis, renal; diabetes, metabolism & nutritional disorders) .

Senior Scientist, Peptide Chemistry Group Leader (Oct-2001 to Apr-2005)

Conducted and supervised research in peptide chemistry group, designed and synthesized novel peptides, peptidomimetic as therapeutic candidates & potential vaccine for Alzheimer disease, developed protocols for animal immunization, supervised and trained chemists in the group, provided scientific and technical assistance to other chemists in the department, generated reports and progress summaries on the research projects as well as collaborated with other groups in the R&D division, managed budget.

• Successfully presented the results in semi-annual and annual Scientific Advisory Board Meetings (SAB)

• Effectively conducted vaccine project and collaborated with an external collaborator.

• Maintained productive collaboration with Biology department, Immunology group and Animal Facility group to ensure the pace and progress of biological part of vaccine project

PERKIN ELMER, Montreal, Canada Jan-1999 to Oct-2001

Senior scientist

Designed and synthesized fluorescent labeled peptides and peptidomimetics as a substrate for orphan receptors (GPCR), supervised and trained scientists and students in the group, provided scientific and technical assistance and support to other scientists in the company.

• Developed a novel approach for synthesis of labeled peptides with acid sensitive fluorescent dyes.

• Maintained a productive training and collaboration with scientists in divisions abroad (Boston, USA and Turku, Finland).

EDUCATION

Ph.D. in Bioorganic Chemistry Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Moscow, Russia

Master of Science, Moscow State University, Moscow, Russia

PROFESSIONAL TRAINING

Risk management planning :An update on health Canada’s interim Implementation May-2010

Data Analysis and SMQs for Physicians / MSSO Apr-2010

Case processing and executing / Synowledge LLC Apr-2010

Implementing and Executing Risk Management Systematically/ BioSoteria Mar-2010

The Fundamental of Signal Detection and Data Mining /Synowledge LLC Feb-2010

Pre-market Safety Surveillance in TPD. Training by CanReg Inc. /Health Canada (Montreal) Oct-2009

EudraVigilance Training Course on E-Reporting of ICSR in the EEA. Training by EMEA (London, UK) Jul-2009

Drug Safety/Pharmacovigilance Training by CanReg Inc. (Montreal) Apr-2009

Good Clinical Practice and Monitoring Training (Montreal) Aug-2008

MedDRA training by MSSO– Chantilly (USA) Jul-2008

Management training: Leadership, Communication and giving feedback Sept-2005

Leadership Grid: The power to change Feb-2003

Building Spectacular Teams: Harnessing Individual Potential to Strengthen the Power of Teams Dec-2003

Building a Spectacular Team Jun-2002

Six Sigma Training: Training Program in Knowledge Based management by Air Academy Associates Mar-2001

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