ANKUSH A. MAHAJAN, MD(Herbal Drug Medicine), MBA, CR-DS-PV

**, ****** ***,***********, *** 3H1

TORONTO,ON, CANADA +1-647-***-**** acrnyd@r.postjobfree.com

PROFILE:

Drug Safety professional with a varied and progressive 7 years of academic training and 1.1 year of professional hands on experience in drug safety case reporting. Experience of reviewing around 3000 protocols and processing adverse drug events into safety database and writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Comprehensive knowledge of ICH -GCP, EMA guidelines on GVP, Health Canada (Division 5) CFR safety reporting regulations and International Drug safety and Pharmacovigilance principles. Possesses proven abilities to work effectively with internal and external stakeholders and to liaise with key opinion leaders.

CORE COMPETENCIES :

1.1 years experience in reporting individual SAE/ADR cases

Remarkable experience of 2153 cases to process, to monitor and follow up Serious Adverse Events, serious and non-serious adverse drug reactions, and medical activities

Extensive knowledge of scientific terms and medical terminology drug safety and drug development process and procedures

Medical writing

Perform thorough literature research to comply with quality of case safety reporting

In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines and Basic understanding of FDA and international regulations

Sound knowledge about Data Monitoring Committee (DMC) and Data and Safety Monitoring Board (DSMB) activities

Proficient in data entry and drug safety database (ARGUS and AERS)

Excellent written and verbal communication skills

Good leadership, analytical, problem solving and time management skills

Proven interpersonal, organizational skills and analytical thinking

PROFESSIONAL EXPERIENCE

Senior Drug Safety Associate Apr 2009 - June 2010

Tata Consultancy Services, Mumbai

Project Description:

We helped client to ensure regulatory compliance, enhance efficiency and reduce costs significantly. We operate within onsite offshore model, where client gets benefit from our domain knowledge, global reach, quality systems approach, multi-disciplinary safety expertise and adherence to reporting timelines of the EMEA, FDA, MHRA and other competent authorities

Responsibilities:

1.Responsible for case intake, duplicate check, and registration

of case in safety database

2.Identify and select routine individual cases (SAE/ADR) for processing, determining appropriate prioritization criteria, and noting reasons for any delays

3.Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness); special scenarios; product complaint information; report ability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.

4.Coded all adverse event terminology, other medical information, and drug information in safety database utilizing MedDRA and WHO-DD dictionaries, in accordance with coding policies and standards.

5.Reviewed case criteria to determine the appropriate workflow for case processing,

6.Writing safety narratives for cases, preparing Periodic Safety Update Reports( PSURs), ICSR case report narrative writing

7.Generate reports, ensuring adherence to regulatory compliance timelines.

8.Understand Pharmacovigilance processes to support and lead process improvement initiatives.

9.Performed quality check.

10.Performed peer review of work produced by other team members.

11.Contributed to allocate incoming requirements to other team members.

12.Provided training to all team members on Pharmacovigilance.

Achievements

Successfully completed 2153 cases assigned on daily basis and Increased clinical pharmacology knowledge with respect to the scientific and regulatory affairs and pharmacovigilance. Contributed to the better quality and net acceleration of data processing.

OTHER PROFESSIONAL EXPERIENCE

Asst.Professor and Head of the Department July 2012 - July 2014

G J Patel Institute of Ayurved Studies and Research Center, Anand, India

Delivered presentations on health issues such as diabetes, hypertension, depression to students

Diet consulting at College attached hospital

Tutored students in academic curriculum

Presented articles in seminars, guest lectures

Assisted with planning of health check up campaigns

ACADEMIC EXPERIENCE

Fellow Research Trainee June 2015 - Present

Clinical Research/ Drug safety/ Pharmacovigilance

Academy of Applied Pharmaceutical Sciences, Toronto, Canada

Extensive training of following topics:

Introduction to Clinical Research and Drug Safety:

International Conference on Harmonization (ICH) guidelines, GCP and reference to GVP and reporting of adverse reactions and trials in special populations. Additionally, safety related topics as the Tri-Council Policy Statement, the Food and Drugs Act, SAP program and privacy statement.

Training on assessment of therapeutic risk management policies, issues in pharmacovigilance, including the legal and historical basis of pharmacovigilance, evaluation of individual adverse drug events, signal detection, active safety surveillance, and medication errors

Clinical Project Management and Project Chart Development

Clinical Data Acquisition, Data Management and Biostatistics

Post Marketing compliance for Safety monitoring and Pharmacovigilance

Clinical Research SOP Development

Clinical Study Protocol and Investigators' Brochure Development

Clinical Study and Safety Reporting Activities

HIGHLIGHTS OF EDUCATION

Post Graduate Diploma in Clinical Research /Drug Safety / Pharmacovigilance

Academy of Applied Pharmaceutical Sciences, Toronto, ON, Canada 2015

Workplace Wellness and Health Promotion 2014-2015

Centennial College, Toronto, ON, Canada

MBA in Pharmaceutical Management 2013-2014

Shridhar University, Rajasthan, India

Master in Ayurved Medicine 2009-2012

Bharati Vidypeeth University, Pune, India

Diploma in Clinical Research 2008-2009

Institute of Clinical Research, Mumbai, India

Bachelor of Ayurved Medicine and Surgery 2003-2007

G S G Ayuveda Medical College, Maharashtra, India

PUBLICATIONS

Research Article Title "Pharmacognostical and Phytochemical Studies of Kukkutnakhi -Aspidium cicutarium - A Folklore plant"

IOSR journal of Pharmacy (e) ISSN -2250-3013,(p)-ISSN: 2319-4219, www.iosrphr.org, Volume 4, Issue 11 ( November 2014), Page- 49-52

Research Project published " Pharmacognostical and experimental evaluation of Tectaria macrodonta{Kukkutnakhi} with special emphasis on anti oxidant, anti inflammatory, and cytotoxic activity." At College of Ayurved, Bharati Vidyapeeth University, Oct 2014

REFERENCES AVAILABLE UPON REQUEST

Contact this candidate