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Results driven for Medical Writing and Pharmacovigilance

Results driven for Medical Writing and Pharmacovigilance

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Published by lisiwang
Looking for a growth opportunity in the clinical research of Medical Writing or Drug Safety/Pharmacovigilance
Looking for a growth opportunity in the clinical research of Medical Writing or Drug Safety/Pharmacovigilance

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Categories:Types, Resumes & CVs
Published by: lisiwang on Feb 04, 2010
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05/11/2014

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LISI WANGLISI WANG
(US permanent resident)State College, PA 16801E-mail: <lisiwang@yahoo.com>Phone : 1-416-877-0058
 
OBJECTIVE:
To seek a growth opportunity in
US pharmaceutical industry
, a role in theclinical research area of 
 
Medical Writing
.
SUMMARY OF QUALIFICATION
Over 9 years of practical experience with global pharmaceutical companies, esp.
clinicaltrial-related Medical Writing
(over 2.5 years)
for regulatory purpose
and
Pharmacovigilance/Drug Safety
(over 4 years).
Ability to set up and manage high quality systems,
from pharmacovigilance to clinicaltrial-related medical writing.
Demonstrated comprehensive knowledge in regulatory compliance,pharmacovigilance & clinical trial process and strategic application of FDAregulations, ICH, GCP;
 proven working knowledge of scientific principles and all phasesof clinical research; ability to summarize complex data and identify relationships.
Master degree
from pharmacology and
M.D. degree
.
Demonstrated good record of effective team/interpersonal skills; ability to manage multiple tasks;and provide creative and practical solutions.
SUMMARY OF SKILLS
Technicalwriting:
Well developed in
writing US regulatory submission-ready reports (drugsafety and clinical trial reports)
, SOPs, working practice documents, protocols, essay & grant proposals, research papers, posters, newsletters.
Computer:
Proficiency with Microsoft Office (Word, Powerpoint, Excel,Access), WordPerfect, Lotus, Outlook and Internet for research.
Languages:
Fluent in written and oral English & Mandarin, some knowledge of French
Science:
Good knowledge of scientific methodology & procedures applied in pharmaceutical industry.
Interpersonal:
Motivated team player and independent worker, with excellent analytical &communication skills, both verbal and written; capable of managing a groupof personnel toward achieving collective results.
Personal:
Efficient and detail-oriented individual who works well under pressure withstrong organizational and project management skills to produce high qualitywork; capable to set up a new system/line of work from scratch; eagerness &aptitude for learning new tasks quickly.
 
LiSi Wang, ResumePage 1 of 3
 
EMPLOYMENT EXPERIENCE
Aug. 2007 – PresentSupervisor, Medical Writing group, Pfizer Research & DevelopmentCenter, China
Set up and leading the local Medical Writing group
to provide input to global regulatory submission by interpreting clinical trial results with clinicians, biostatisticians, clinical pharmacology specialists and principle investigators, facilitating key message meeting and results review meeting with clinical studyteam members, effectively implementing medical writing process, independently writing, reviewing andQC
FDA/ICH-compliant
clinical documents (all English), eg.
clinical study reports
(including all efficacy, PK/PD, safety narratives and safety results for full CSR, synopsis CSR, coreCSR)
,
PhRMA Web Synopsis, CTD documents, clinical protocols for variousPfizer global clinical trials
, according to ICH and Pfizer global standards, in varioustherapeutical areas (metabolism, inflammation, pain, ophthalmology, cardiovascular, endocrinology,neurology, allergy, respiratory and oncology).
Established new-hire training strategy and system; developed project management & quality metricstool and system; facilitated external & internal audit and inspection.
Being a people manager; involved in interviewing, hiring and mentoring new staff.
Feb. 2006 - Jul.2007Senior Pharmacovigilance Specialist, BaxterCorporation, Canada
Established and maintained an efficient pharmacovigilance system
 by setting up electronictracking system, training system; developing SOPs & working practice documents; supporting globalADR/AE database (AERS); joining in Baxter global medical doctor team to create the convention of vigilance strategy for global usage; facilitating Canadian inspections and corporate audits; creatinginternal departmental website.
Conducted pharmacovigilance activities:
collect, investigate, process, document and report allapplicable local and foreign ADRs from post-marketing & clinical trials in accordance with globaland national regulations and procedures; detect potential safety signals and assess the relevant data toevaluate benefits and risks of Baxter products.
Established appropriate contacts
with external parties (FDA & Canadian regulatory authority,health care professionals, distributors) and internal parties (Baxter global pharmacovigilance,regulatory affairs, quality, sales & marketing); answer safety-related inquiries; provide input toRegulatory Affairs in product labels/monographs and input to sales & marketing incontracts/agreements
Set up and implemented a training program
to train customer-facing personnel (e.g. sales rep,customer service, etc)
 
to enhance the awareness of the importance in monitoring drug safety and thevisibility of pharmacovigilance function within the company.
Dec. 2003 -Feb. 2006Pharmacovigilance/Medical
 
Information Specialist, Genpharm Inc.(A Division of Merck KGaA, Germany), Canada
Conducted pharmacovigilance activities:
AE coding (MedDRA); collect
,
review, and assess allsafety data; write and report individual AE case report (15-day report), PSUR/PADER, special safetyreports, communicate with FDA/TPD for drug safety issues.
Conducted medical information tasks:
provide verbal or written medical or drug-safetyinformation to consumers, health care professionals and marketing department upon request.
Established and organized local database to manage
 
and track all drug safety cases and activities; performed routine case review; supported global pharmacovigilance database (ARISg), activelyinvolved in the creation and implementation of strategies to improve operations; Initiated SOPs andchange controls.
LiSi Wang, ResumePage 2 of 3

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