Drug Safety Physician in pharmacovigilance

-DR. JAYASHREE KHADTALE

Phone: +1-609-***-**** Email: < **********@*****.*** >

Senior Drug Safety Physician and Drug Safety Specialist in Pharmacovigilance, Signal detection and PSUR DSUR content writing experience in the form of AOSE (analysis of similar events) writing and company comments, performing AE dedicated review, Clinical SAS Programmer, Medical Doctor, Administrator, Manager, Trainer in pharmacovigilance and medicine.

Work Authorization: Green Card Holder, I am authorized to work in US for any employer.

AWARDS AND RECOGNITIONS:

WOW Award (Cognizant Technology Solutions) October 2013.

OPEL Award (Cognizant Technology Solutions) January 2014.

For outstanding performance, productivity and dedicated service.

WORK EXPERIENCE:

10 years in the field of Drug Safey Pharmacovigilance and Clinical Research as:

Worked for 7 years in Pharmacovigilance : 4 years as a Sr. Drug Safety Physician and 3 years as a AE Reporting Medical Officer in Public Health institutions.

Worked for 3 years as Advanced Clinical SAS Programmer (statistical programming for safety and efficacy of the drug using aggregate AE reports as source documents).

Clinical Research Associate volunteer work at PHRI.

Worked for 22 years, as a Medical Doctor and managed Clinical and Administrative work.

EDUCATION:

MBBS (India), Medical Doctor Degree evaluated by WES to be equivalent to MD.

Advanced and Base SAS Programming, USA certifications.

TCPS 2: CORE, Clinical Research certification.

Review of Health Records, Clinical Research certification, HHS, Canada.

KEY SKILLS:

Clinical Research Experience: As a Drug Safety Physician (Serious (spontaneous, solicited, clinical research, legal) AE reports from worldwide sources), and clinical SAS programmer (Certified Advanced and Base SAS programmer, USA).

Signal detection and PSUR DSUR experience in the form of AOSE (analysis of similar events) writing company comments and PSUR, DSUR contents, performing AE dedicated review Review of SAE reports (coding, labeling, causality, seriousness).

Query generation, AE dedicated review, SAE reconciliation, vendor QC, Training etc

Knowledge of FDA, EU, Health Canada Drug Safety Regulations and ICH guidelines.

Working knowledge of MedDRA dictionary and WHODD with relevance to SAE analysis and SAE coding.

Experience in ARGUS and ARISg database.

Experience in Oncology, Biologics, Immunology, Anti Diabetics, Anti malignant, Human vaccines, Multiple Sclerosis, Anti coagulants, Anti arrhythmic, Anti allergic, CNS, OTC products.

Business Management: Can efficiently handle all fronts of the Business.

Medical Knowledge and Experience.

Microsoft Office proficiency.

Trainer for pharmacovigilance and medical staff, community health workers and medical and nursing students.

Excellent communication skill.

WORK EXPERIENCE:

Medical Advisor/ Case Medical Evaluator Expert (contract): Global Drug Safety Physician role

Sanofi Aventis, Bridgewater, New Jersey, USA (May2017 onwards, Contract)

Phase I II III IV Clinical Trials (Biologics, anti-rheumatoid arthritis, antidiabetics, MS)

ICSR processing for Serious Clinical Trial case reports for pre-marketed drugs as a Case Medical Evaluator Expert, using AWARE (from Oracle Clinical)

Analysis of similar events(AOSE) and Medical comments in support of Signal Detection

Deciding about seriousness, listedness, relatedness, reportability to FDA and other health authorities.

Query generation for submitting to study investigator.

Writing AOSE and Company comments

AEDR (Dedicated Review of Adverse Events)

eCRF Specs Review

SAE reconciliation

Vender QC

Sr Drug Safety Specialist:

Johnson and Johnson Janssen Inc., Toronto, Canada (May 2015 – May2017, Contract)

Working on Biologics, Immunology.

Case processing using ARGUS, for Solicited Serious and Non-Serious AE reports, Triaging : deciding about Seriousness, Listedness, Relatedness, Duplicate search, Prioritizing, Reportability to Health Canada, Coding AEs using Med DRA and drugs using WHODD, deciding about Lack of Efficacy and forwarding case to Product Quality Dept., deciding about Due Diligence (Follow up priority), instructions for further case processing team through notes, Query solving, Follow up with the reporters, Communicating with Global case processing team, Train junior drug safety associates and other related work using Medical knowledge and Experience in Pharmacovigilance.

Clinical Research Associate (CRA) volunteer, Population Health Research Institute (PHRI, Canada), Longitudinal Population Research Study (Jan 2015- March2015):

Data entry and Validation work using DATAFAX database.

Data Management work.

Senior Drug Safety Physician: Global Drug Safety Physician role

Cognizant Technology Solutions (March2013-December2014): Worked for Sanofi Aventis, Zentiva, Sanofi Pasteur, Genzyme, Chattem.

Worked in therapeutic areas of Medical Devices, Anti-Diabetics, Anti-Malignant, Human Vaccines, Multiple Sclerosis, Anti-coagulants, Anti-Arrhythmic, Anti-Allergic, Central Nervous System and OTC products.

ICSR processing for Clinical Trial, Post Marketing, legal, literature and line listing Cases using Oracle ARISg (AWARE) and Siebel, for Serious AE reported from Worldwide sources: Determining Causality, Relatedness, Expectedness and Seriousness, Case Priority for Regulatory Reporting, Coding Drugs and Adverse Events, Writing PVP Comments, Determining Chronology of AEs as per seriousness and expectedness.

Determining types of Medication Errors, Referring to CCDS, IB, Local Data Sheets, and Generating Outbound Queries for getting additional information etc.

MedDRA and WHO-DDE coding.

Ensure quality, accuracy, and medical safety standards and oversee execution of Quality Control and discrepancy management for Case Processing work.

Managing Work distribution, deadlines and priorities.

Manage and lead the team and ensure that all tasks are performed in accordance with organization’s policies, guidelines and standard operating procedures.

Training and mentoring safety process associates/trainees as per requirement.

Preparation of training materials.

Coordination and Business communication with the Client.

Preparation of monthly compliance reports and CAPA advices for non-compliance.

Analyst SAS Programmer:

Cognizant Technology Solutions (June2012-February2013) for Novo Nordisk

Freelance SAS programmer (September2011-May2012): for Indian Pharma

Statistical Programmer, i3Statprobe (May2011-August2011)

Cliplab, Cytel Statistical Software and Services (2010)

Programing for Tables, Listings and Figures, and for Integrated Summary Statistics.

Macro for generating outputs of three sections at a time -overall Lab listings.

Analysis and Derived data set creation and validation.

Macro Training work: Preparation of power point presentation for Macro and SQL.

Preparation of Define Documents, and QC Define Documents.

Annotations of CRF, and empty shells.

SQL.

Create RTF, PDF, HTML listing tables reports using SAS/ODS.

Data reconciliation for Phase III studies of clinical trial.

Medical Doctor and Administrator:

Jeevan General and Maternity Hospital, Mumbai (1994-2009): Founder and Chairman,

Efficiently handled all fronts of the business, administration, clinical, operative patient care, stock management, recruitment etc.

Trained staff and nurses.

Health Department, Bombay Municipal Corporation (1991-1993):

Full time Medical Officer: administrative and clinical duties

ICSR reporting in CDSCO Suspected Adverse Drug Reaction Reporting Form, as per CIOMS and ICH guidelines, to the Head office.

Supervised and headed a staff of 80 employees in various hospitals.

Recruited staff, scheduled work and assignments.

Trained staff, auxiliary nurses and midwife, community health workers.

Adapted and revised operational and business targets.

Coordination with the head office and maintained events with updates.

Disease surveillance activity and Reporting under various National disease control programs under WHO guidelines.

Organized and successfully accomplished Health Camps in Rural areas.

J.J. Group of Hospitals, Mumbai (1988-1990):

Full Time Post graduate Resident medical doctor in the department of gynecology and obstetrics.

Trained the medical students.

Clinical duties of treating and operating on patients.

Participated in Clinical trials.

General Medical Practice (1986- Dec. 2014)

Post-graduate Internship (1985- 1986)

Medicine, Surgery, Pediatrics, Psychiatry, Obstetrics, Gynecology, Preventive and social medicine, Ophthalmology, ENT, Orthopedic, Emergency medicine, Rural and Urban Community Care completed.

TRAINING ACTIVITY:

Training experience of 22 years in medicine.

Trained medical students, staff, nurses and community health workers.

Provided training of SAS.

Training to medical reviewers and drug safety associate.

EDUCATION and PROFESSIONAL CERTIFICATIONS:

Post-graduate Medical Training:

Post-graduate Residency in Obstetrics and gynecology at Grant Government Medical College, J.J. Group of Hospitals, Mumbai

Post-graduate Internship in an Accredited University Teaching Program, in Medicine, Surgery, Pediatrics, Psychiatry, Obstetrics, Gynecology, Preventive and social medicine, Ophthalmology, ENT, Orthopedic, Emergency medicine, Rural and Urban Community Care completed.

Graduate Medical Degree Training:

Medical Doctor Degree: M.B.B.S. (Bachelor of Medicine, Bachelor of Surgery) from University of Mumbai, India. Medical Course completed and passed from Grant Government Medical College, J.J. Group of Hospitals, Mumbai, India (WHO/ FAIMER/FMRAC approved Institution)

Medical Council Registration and Licensed member.

Relevant Certifications:

TCPS 2: CORE, Clinical Research certification.

Review of Health Records, Clinical Research certification, HHS, Canada. (Hamilton Health Sciences, Canada).

Advanced SAS Certification.

Base SAS Certification.

MS-CIT (Certificate in Information Technology) completed from Board of Technical Education. Government of Maharashtra.

PRESENTATION and LECTURES:

PowerPoint Presentation of Signal Detection in Pharmacovigilance.

Presentation and lecture at Department of Microbiology, Grant Government Medical College, J.J. Group of Hospitals.

VOLUNTARY WORK EXPERIENCE:

I have organized, executed as well as participated in many Health Camps.

Voluntary service in meditation camps held on week end.

Counselling and supervising Maternity and Child Welfare Program.

Fund raising for poor, helping students, various other community activities.

REFERENCES :

From Sanofi :

Dawn Sanderson Bongiovanni, Director (Retired now), Drug Safety, Sanofi, Bridgewater

+1-908-***-**** *****@*******.***

Jiang Jason, Manager, Drug Safety, +1-908-***-**** *****.*****@******.***

From Johnson and Johnson

Caroline Grenier 416-***-**** (Ontario, Canada) ********@***.***.***

From Cognizant

Dr.Baseer, Manager at Cognizant, currently in US, **********@*****.***.

Sourabh De email : *******.**@*********.*** (My DGM at Cognizant).

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