Page * of *

INDIVIDUAL EXPERIENCE RECORD Strictly Private

Leila Neese Hamidi LNH

NAME

(First, Last, Initial)

** / ** / ****

DATE OF BIRTH

(Mo/day/yr)

French/ US Permanent Resident

CITIZENSHIP

3367 Vittoria Loop

ADDRESS

Dublin, CA 94568 - USA.

Cell: 925-***-**** ; Home: 1-925-***-****

e-mail: acdzrx@r.postjobfree.com

EDUCATION

School & Location Curriculum or Major Dates Attended Degree

London, EMEA, E-reporting of ICSRs in the EEA Dec.2005 Certified for EudraVigilance

(incl. EVCTM & EVMPD)

Paris VI, Medical law - Legal medical appraisal 0ct. 2000 University-Diploma-Master

in Medical & Public Health law.

DEA –CCA in ICU

Paris XII, University Hospital Emergency care June -1997

Drug Safety & Clin.Pharmacol in Elderly patients June -1992 PhD in Spec Anesthesiology-Rea

Faculty of medicine of Paris XII 1982 -1988 General Medical Graduation

National Veterinary School of Maisons Alfort (FR) 1981 -1982 Veterinary Medicine degree.

Mathematics Baccalaureate June -1981 High school Diploma

M AJOR PROGRAMS & TRAINING (Show formal training programs)

Management Product safety within REMS/RMP, Certificate, Boston, MA April 2011.

Signal Detection & Interpretation in Pharmacovigilance, Certificate London June 2007.

Global Pharmacovigilance and Risk Management Strategies in EU & USA, Paris Mar.2006.

EudraVigilance training: Electronic Reporting of ICSRs in the EEA, at EMEA / London 2005.

Essential training in Global Pharmacovigilance, with the IBC Life Science / Paris Feb. 2004

Implementing the EU Clinical Trial Directive: A Pratical Interpretation with IBC / Brussels 2003.

Medical Approach in Diagnosis and Management of ADRs with DIA / Paris 2003

Data Analysis and Query Generation using MedDRA – MSSO /London, UK in 2002

Training on “Alert in Pharmacovigilance practice” in April 2001 in (Bordeaux)

Graduation then participation in clinical cases validation program for severe skin drug reaction’s in 1999,

2000 & 2001 (EUROSCAR).

Training on” Epidemiological method for evaluation of drug risk" in Oct. 2000 (Bordeaux)

Training on “Evaluation of drug induced liver disease” in May 1999 (Dijon)

Training of oral and gestural communication in March 1996 with GIEF consulting.

University diploma of neurovascular imaging (X-ray angiography, CT -scan and magnetic nuclear

resonance) in June 1995, 2000 & 2005.

PROFESSIONAL EXPERIENCE SUMMARY (Identify specific competencies, e.g. functional, product, market, customer, technical)

Please, see next page

OTHER QUALIFICATIONS (Professional licenses, honors, patents, awards, special recognition, community experiences, etc.)

Active Member of DIA (Drug Information Association

Member of the European Society of the Clinical Pharmacology.\

Member of the European Association of Pharmaco-Epidemiology

GEOGRAPHIC CONSIDERATIONS (Indicate limitations, strong preferences, timing). Are you interested in assignments outside your

present country location? (Y/N)

Yes

LANGUAGES (Describe first/second/third language proficiencies)

English

French

/Continuum/

Page 2 of 5

/Continuum/

Strictly Private

INDIVIDUAL EXPERIENCE RECORD

Hamidi – Leila -LH

NAME

WORK EXPERIENCE Begin with first position held. Include military service and work with other companies

Dates Company/Location Position / Main responsibilities

Sept.13 to Apr 14 Acadia Pharmaceuticals Sr. Director, Head of Clinical Safety &Pharmacovigilance (Consultant)

-Safety oversight of out and in sourced activities within Clinical Trials Ph3.

San Diego

CA -USA -Ensure that all Pharmacovigilance and safety activities are performed in

accordance with Regulatory requirements, company policies and dev. projects.

-Oversight of End-to-end safety operations for individual and aggregated safety

case assessments and management of resources allocated to tasks executions.

-Provide medical expertise and judgment to proactively detect safety issues,

potential risk/benefit change and propose strategies for risk mitigation .

-Collaborate with Clinical data management for data reconciliation,

Contribute to Vendors Audit for compliance and Vendors inspection readiness

Review and update Safety Management Plans and Master Service Agreement. .

-Lead Safety medical expertise and judgment for the preparation and

maintenance of Dev.Risk Management Plans.

-Responsible for leading preparation and development of safety summaries

for INDs/CTAs/NDAs/MAAs and other regulatory documents

-Contribution to CQA activity for inspection reediness, training material preparation,

Data integrity verification and archiving territorial compliance.

-Ensures appropriate safety SOPs are developed, maintained and implemented

-Responsible for summarizing safety information and providing strategy for safety

updates into clinical and regulatory documents including protocols, CSR’s, IB’s.

-Lead and foster cross functional ad hoc committee meetings where safety updates

and potential safety emerging issues will be discussed.

Apr.12 –Sept.13 FibroGen Inc. Sr. Director, Head of Drug Safety &Pharmacovigilance

San Francisco, - Identify and evaluates fundamental issues, providing strategy and direction for

CA -USA major functional areas involved in all aspects of clinical development activities. .

- Interacts internally and externally with executive level management requiring

negotiation of extremely difficult matters to influence policymaking bodies .

- Lead and directs the Drug Safety Team and all aspects of drug safety related to all

company sponsored clinical development activities to manage patient safety and

compliance with regulatory reporting requirements.

- Actively participate in oversight of patient safety in all on-going clinical trials.

Directs and conducts ongoing safety surveillance of company drug products.

- Manage internal staff and external resources to ensure delivery of quality

pharmacovigilance services.

- Negotiate contracts, interacts and supervises the activities of contract

organizations and consultants for pharmacovigilance services.

- Provide ongoing advice to senior management on the changing risk -benefit profile

of company drug products in clinical trials, based on analyses/evaluation of

potential safety signals and implements appropriate safety updates and risk

mitigation plans.

- Provide oversight of all clinical safety services including review of medical coding of

adverse event data and management of SAEs through the entire lifecycle including

preparation of similar-event analyses for unexpected and related serious adverse

events (SAEs) from clinical trials.

- Manage compliance with SOPs, and FDA/EMA/PMDA and global regulations for

the reporting of adverse events to regulatory agencies, IRB/Ethics committees and

Investigators.

- Supports cross functional departments and personnel to ensure safety training and

compliance, and readiness level to pass internal/external audits or inspections.

- Direct the development, preparation and compliance of periodic and annual safety

reports (eg. US IND annual progress reports, EU annual safety reports, periodic

line listings, NDA safety updates, etc.), investigator communications, product

labeling/package inserts and other reports as necessary.

- Provide medical expert safety review input into all critical documents for clinical

development of products (eg. protocols and amendments, ICFs, IBs, IMPDs,

Page 3 of 5

clinical research reports,, INDs, CTAs, etc). Establishes and manages

independent Data Safety Monitoring Boards (DSMBs) for clinical studies.

- Participate in corporate development of methods, techniques and evaluation

criteria for projects, programs, and people. Ensures departmental budgets and

schedules meet corporate requirements

June 11- Apr. 12 -Amgen Inc. Safety and Regulatory Business Process Owner (50%)

Global Safety Director -Subject Matter Expert (SME) for Global Safety Business Process and System

Thousand Oaks – CA, USA operational validation, improvement and upgrade.

-PV Operation Inspection readiness and preparation of answers to CAs.

-Translate into the business process worldwide regulatory requirement

related to drug safety and drug and Device Risk management.

-Work cross functionally on FDA new rules, their implementation.

-Lead Work stream, and deliver implementation plan for the New EU

-Regulation related to EMA Roadmap to 2015 as well as the

“Transitional Measures” for Safety processing and reporting according to

the new requirements for the GVP 2012.

June 11- Apr. 12 -Amgen Inc. Lead Physician for signal detection within Maternal, Lactation and

Global Safety Director Pediatric Pharmacovigilance for 50%.

Thousand Oaks – CA, USA -Execute medical review of pregnancy and lactation cases received

through Amgen's Pregnancy and Lactation Surveillance Programs and

perform aggregated cases analysis & provide relevant statement on B/R.

-Work with Pre-clinical, Regulatory and Clinical depts. on specific Risk

detection, Assessment and Minimization in pregnancy and Pediatric groups.

-Work on Amgen Global safety pediatric programs.

-Participate to build literature search strategies, perform articles safety

content analysis and discuss detection of potential safety risks.

Jan 09- June 11 Amgen Inc. Safety Compliance Program Business Lead for Case Management

Global Safety Director Subject Matter Expert (SME) for Design, testing and implementation Thousand

Oaks –CA, USA of Argus Safety Database

-Provide Subject matter expertise for Business Process for Argus

database Business Configuration and implementation

-Lead workshops to support cross functional requirements for safety compliance

-Assure global regulatory are consideration into the process

Participate to training material preparation and training delivery for

international Argus users

database training

Liaise with Global Proactive Surveillance team as Safety SME.

Sept 06-Jan 09 Amgen Ltd. Global Safety Director & EU Deputy QP

Global Safety Director Medical Safety Operation as Med Reviewer for individual cases.

Uxbridge – UK Medical and regulatory backup for EU Hub and Local Safety Offices.

Core Member of IPRC for Safety as protocol reviewer

Core Member of RIMA as Safety liaison into Medical Affaires Reach.

May 05-Sept 06 HRA Pharma EU-QP and head of central Pharmacovigilance with responsibility:

HQ Product Safety Dept -Post marketing and investigational safety management

France – Paris -Setting up new process based the compliance with Vol.9 and

2001/20/EC, including the specification for cell therapies

-Carrying out SOPs, Policies, and Working Practices

-All staff training to PV Global SOPs and preparation to Inspections

-Develop Process for EU & US+JP regulatory requirements

-Routine Pharmacovigilance activities and risk management plans

-Implementation of new Drug Safety System for electronic

transmission and ICHE2BM compliance (ARISg)

-Team leader for preparation of PV contract with partner, licensees

and CRO incl. Data exchange, in development or post market.

Apr 02-Apr 05 Pierre Fabre Médicament Central Drug Safety Manager for worldwide

HQ Product Safety Dept marketed and investigational drugs in oncology TA.

France – Boulogne -Driving and coordinating 6 associates (MDs, Scientists & Pharm ).

-Providing EU-HA with answers to safety questions and preparation

of drug safety concern ad hoc reports.

-Participation to the team crisis management.

-Overseeing preparation and signing PSURs for marketed products.

-Coordination and review Annual Safety Report for study drugs

-Leading safety labeling update into DCSI, CCDS & IBs for oncology

closely with regulatory and clinical develop teams.

Page 4 of 5

-Global safety support affiliate and licensee for SmPCs update and

harmonization cross EU, Asia territories.

-participation to the PVG process periodic training for the subsidiaries

Safety staff.

Updating the top mgt on product B/R ratio & running workshop on

safety –regulatory practices and challenges.

-Outside the company participation to international scientific meetings

around EU- Clinical Trial Directive.

1999 - 2002 CS&E Novartis Basle-CH Global Safety Medical Expert for marketed and investigational drugs

in immuno-transplant, endocrinology, gyneco-obstetrical and oncology TA.

Responsibilities:

-Quality Compliance of Data collection and medical writing, data analysis and risk

assessment.

-Testing, assessment and development of a global safety system using Argus

Relsys database. Participation to data migration process.

-Individual and aggregated data analysis for risk detection, risk evaluation and

presentation to ad hoc global safety meeting for decision making in term of safety

risk management including labeling impact.

-Management of SUSARs & IND reports for company sponsored

clinical trials. Generating communication for Investigator Alert or Notification.

Overseeing preparation and reviewing PSURs and IBs revisions.

Organization and management of a large Compassionate

haemato-oncology drug use program in collaboration with local Health Authorities.

Writing rational for specific safety issues or supporting product B/R

changes, this proactively or as answers to Health Authorities inquiries.

Organization and management of medical information related to

products safety to be used by various stakeholders.

1997 - 1999 CS&E Novartis France Safety Medical Expert for marketed and

investigational drugs in immuno-transplantation and dermatology

therapeutic areas.

Writing the periodic safety reports for the local HA submission.

Preparation of standardized written answers to the health

Professionals and consumers for marketing use on the company

products

Preparation and collaboration to the regulatory tasks (preparation of

the product information package) and oversee marketing Comm. & Pub

1994 – 1997 PVG Sandoz France Safety medical expert for marketed Sandoz drugs

used in cardiovascular, dermatology, pneumology,

Rhumatology and Gyneco-obstetrical therapeutic areas

1993 – 1994 PVG Roussel-Uclaf Safety medical expert for marketed and investigational.

Head of PVG Roussel France division therapeutic areas.

1992 – 1993 Regional center of Member of AFSSAPS safety committee (share time with PH-APHP)

Pharmacovigilance Assistant of Pharmacovigilance, responsible for

of Créteil 94 supervision of residents training, writing and assessing

the case adverse reaction reports.

Taking part in the national inquiry of Pharmacovigilance.

Preparation of the health authority’s technical meeting.

1990 – 1994 Hospital Intercommunal of Praticien Hospitalier APHP/Hospital Pract Public Ass Hosp Paris.

CHU. Créteil 94 France Anesthesia and reanimation, responsibility for Anesthesia drugs and protocols

choice according to surgical operations, underlying disease of each patient and to

manage the post-operative supervision and analgesic control therapies and

recovery process.

1988 – 1990 Medical experiences

Hopital Henri Mondor of Resident in Neurology department with Pr. Degos.

CHU. Creteil 94- France

Hopital Albert Chenevier Resident in Internal medicine dept. with Pr. Leparco

CHU. Créteil 94- France

Hopital intercommunal of Resident in Pediatric and neonatology, Pr. Reinert

Créteil 94- France

Hopital Henri Mondor Resident in Surgical Reanimation, Intensive Care Units with Pr Huguenard

CHU. Créteil 94- France

Hopital Ste Camille of Resident in Cardio-Pulmonary with Pr Estampe.

Brie sur Marne 77- France

Hopital Henri Mondor of Resident in Medical Cardiology dept. of Pr. Vernant

CHU. Créteil 94- France

Page 5 of 5

1986 – 1988 Surgical experiences

Resident in Orthopedic surgery in Pr Kenesi’s depart

Hopital Henri Mondor

Créteil 94, France Resident in General Visceral & Gastro-Intestinal surgery - Pr Julien.

Resident in Cardio-Thoracic surgery with Pr Cachera

Hopital Intercommunal Resident in Gynecology-Obstetrical surgery with Pr Paniel.

Créteil 94, France

Last Update April 14st 2014

Contact this candidate