Highlights of Qualifications

OBJECTIVE:

A highly self-motivated professional seeking a challenging role in Drug Safety where I can utilize my qualifications and skills towards accomplishing tasks and grow in my role.

SUMMARY:

10 years of experience as a Medical Associate, with therapeutic expertise in respiratory and infectious drugs. Around 3 years of pharmacovigilance experience as a Drug Safety Associate for both clinical and post-marketing drugs.

Extensive knowledge of US and ICH safety reporting regulations and guidelines.

Interest and basic knowledge of drug development process, clinical trial process and clinical development plans.

Experience with MedDRA, WHO Drug dictionaries.

Proficient in data entry and drug safety database (ARGUS)

Knowledge of different therapeutic areas- Respiratory/Infectious/Cardiovascular

Understanding of FDA and international regulations.

Familiar with the use of search engines like PubMed, EMBASE, OmniMedicalSearch.com, Guideline.gov, Journal Watch, ClinicalTrials.gov, CenterWatch.com, eMedicine.com, RxList.com, etc

Proficiency in computer applications like MS Office.

Excellent communication skills, both written and verbal.

Proven interpersonal, organizational skills and analytical thinking. Demonstrated ability to adapt quickly, prioritize tasks appropriately and work as a team.

Possess good leadership, problem solving and time management skills.

Eight years of practicing Medicine and Surgery in teaching and community hospitals.

In-depth knowledge of clinical research and drug safety principles.

DUKE MEDICAL CENTER, DURHAM, NC 04/2012-PRESENT

CLINICAL SCIENTIST

Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.

Familiarity with the following: safety databases, data entry platforms, adverse event data collection process, case processing unit, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.

DRUG SAFETY ASSOCIATE, Qtech SOLUTIONS INC.NJ 08/2012-07/2014

Received and processed ICSRs from clinical trial, spontaneous and from published reports.

Data entry, case processing and coding in MedDRA of serious adverse events received in compliance with SOPs and regulatory requirements.

Performed triage for seriousness, relatedness, and expectedness and prioritized of incoming adverse events as per the protocol, investigator brochure, and/or labeling.

Confirmation of initially entered data and follow-up information for ICSRs onto the Drug Safety database in accordance with the current Data Entry and Process Instructions and associated SOPs.

Generated well written, concise and accurate narratives for both serious and non-serious cases.

Maintained accuracy, consistency and completeness of safety databases and tracking log.

Assisted with the AE-SAE reconciliation process.

Review of individual cases to update Company Core Data Sheet and Safety Information.

Communicated with physicians, study coordinators and consumers to obtain all relevant safety information.

Experience in Post Marketing Documentation under 21 CFR Part 11, GCP, GLP, and ICH guidelines.

Planned, organized, and managed daily work to meet timelines.

LABCORP CLINICAL TRIALS, DURHAM, NC (CRO-Contract) 03/2011- 07/2012 CLINICAL TRIALS MONITOR

Act as the main line of communication between the sponsor and the investigator

Responsible for the proper conduct throughout the trial

Verifying that the investigator follows the approved protocol and all GCP procedures

Verifying that source data/documents and other trial records are accurate, complete, and maintained

Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

Company and Sponsor Standard Operating Procedures (SOPs).

Mentors and coaches site activation staff.

Receipt administrative and regulatory documents.

Coordinates the packaging, shipping, and tracking of study supplies and materials.

RICHARD WEISLER, MD., P. A. & ASSOCIATES, RALEIGH, NC 02/2009- 02/2011

CLINICAL STUDY COORDINATOR

Oversees day-to-day activities for AE and SAE reporting, SAE EDC data entry and query resolution

Manage drug accountability

Maintain study file notebooks

Communicate verbally and in writing with sponsors, CRAs and Principal Investigators

Query sites for missing/discrepant information with due diligence

INVENTIV CLINICAL SOLUTIONS, INDIANAPOLIS, IN (CRO-Contract) 07/2008 to 01/2009

DATA MANAGER II

Responsible for managing study data for a project from database development to data lock and overseeing the DM tasks to ensure all specifications are being followed.

Adverse Event (AE) receipt, data entry, and evaluation. Ensures compliance with standard operating procedures (SOPs), and adheres to Food and Drug Administration (FDA) regulations

DUKE MEDICAL CENTER, DURHAM, NC (Academia) 04/2007- 06/2008

CLINICAL RESEARCH COORDINATOR, ANESTHESIOLOGY

Coordinated clinical trials in the Department of Anesthesiology

Submit AE/SAE per protocol to sponsor

Submit adverse events and IND safety report to IRB.

Review and process serious adverse events reported during clinical trials.

Write medically accurate narrative description of event from information supplied in the source documents

RICHARD WEISLER, MD., P. A. & ASSOCIATES, RALEIGH, NC

CLINICAL RESEARCH COORDINATOR 09/2006- 04/2007

Oversees day-to-day activities for AE and SAE reporting, SAE EDC data entry and query resolution

Manage drug accountability

Maintain study file notebooks

Communicate verbally and in writing with sponsors, CRAs and Principal Investigators

Query sites for missing/discrepant information with due diligence

DUKE MEDICAL CENTER, DURHAM, NC 12/2004- 08/2006

CLINICAL SCIENTIST, HEMATOLOGY

Process and perform A-PTT, PT, Fibrinogen, D-Dimer, Factors II, V, VII, VIII, IX, X, XII Activity.

Processing of thrombosis panel, lupus panel and Elisa Dimer, Quality control and Quality assurance

DUKE CLINICAL RESEARCH INSTITUTE, DURHAM, NC( CRO- Contract) 01/2001- 11/2004

DRUG SAFETY ASSISTANT III

Data entry, case processing and coding in MedDRA of serious adverse events received in compliance with SOPs and regulatory requirements.

Performed triage for seriousness, relatedness, and expectedness and prioritized of incoming adverse events as per the protocol, investigator brochure, and/or labeling.

Confirmation of initially entered data and follow-up information for ICSRs onto the Drug Safety database in accordance with the current Data Entry and Process Instructions and associated SOPs.

Generated well written, concise and accurate narratives for both serious and non-serious cases.

Maintained accuracy, consistency and completeness of safety databases and tracking log.

Education

University of Peshawar, Peshawar, Pakistan, 1982 MBBS ( Bachelor of Medicine and Bachelor of Surgery)BS

CAMPBELL UNIVERSITY 2007 MS (PARTIAL FULFILLMENT FOR THE

MASTER PROGRAM IN CLINICAL RESEARCH)

SCHOOL OF PHARMACY, NC

Professional Memberships & Certifications

Certified Drug Safety Associate-Trials (Qtech-Sol Professional Development Center, NJ)

Certified Medical Technologist ASCP (Hematology and Clinical Chemistry)

Member Society of Clinical Research Associate (SoCRA)

Clinical Research Associate Level I Certification Program, Durham Technical Community College, Durham, NC

Certified Phlebotomist by American Society of Phlebotomy Technicians

Computer Skills

Clintrial, Microsoft Office (Excel, Word, PowerPoint), WordPerfect. Phase Forward InForm EDC application, Clintrace, AERS. ARGUS, LIS, PATH NET. BEAKER.

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