S.RAJU

Mobile +91-988*******

E-mail ac0bx2@r.postjobfree.com

Career Objective:

Trained, dynamic and skilled professional with experience in pharmacovigilance.

To work in a creative and collaborative environment where my analytical skills, drug safety and academic knowledge will contribute to the overall goal of the organization while further developing my leadership, organizational and technical skills.

Professional Summary:

3.10+ years of pharmacovigilance/drug safety experience.

Extensive knowledge and working experience in Oracle Argus safety database and Proficient in the use of WHO Drug Dictionary, MedDRA coding browser etc., in QuintilesIMS, Bangalore, INC Research, Gurgoan and Icon clinical research, Chennai.

Have completed one year PG diploma in clinical research course.

In-depth knowledge in various report types like literature reports, spontaneous reports, Clinical trial, E2B report etc.,

Strong knowledge in MedDRA coding principles, submission criteria, regulatory timeline requirements, technical requirements and ICH guidelines.

Remarkable knowledge of scientific terms and medical terminology and proficient in narrative writing and Argus drug safety database.

Professional Experience:

QuintilesIMS, Bangalore, India

Duration: Aug-2016 -Present

Designation: Operations specialist

Job Roles:

I will Interface between company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems. I will review the entire case, identify the ICSR criteria’s as per SOP and data base it.

I will write concise, accurate and well-written case narratives. I will write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.

I will perform coding of all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g. MedDRA, company product dictionary, WHO-DD).

I will process the patient data, assess the seriousness, and monitor the adverse events, perform coding of the events with the help of MEDRA, perform labeling of the events according to the specific product RSI.

I will review and verify the appropriate selection of SAEs from source documents for appropriate MedDRA coding and select product for WHO Drug Dictonary coding.

I will discern what information requires querying and will interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved.

I will perform quality review of the whole ICSR cases, Mentor junior staff; also undergo development and provision of training within specific areas of knowledge.

I will perform other activities like presentations regarding safety and pharmacovigilance to internal and external customers as identified and requested by management.

INC Research, Gurgaon, India

Duration: Mar 2015- Aug-2016

Designation: Safety Specialist 1

Job Roles:

I will review the case, process, capture the adverse event reported and write narrative according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.

I will write concise, accurate and well-written case narratives. Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.

I will perform coding of diseases as well as adverse events according to the project-specific coding conventions. Process the patient data, assessing the seriousness, monitoring the adverse events, coding of the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet.

I will perform coding of drug appropriately as per WHO-DD and will review and verify the appropriate selection of AEs from source documents for appropriate MedDRA coding.

I will undergo development and provision of training within specific areas of knowledge.

I will maintain understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.

I will perform other activities as identified and requested by management.

Crest, Pune, India (www.crest.in)

Duration: Apr 2014- Dec 2014

Designation: Scientific and medical writer grade 1 officer

Job Roles:

I will review the case, process, capture the adverse event reported and write narrative according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.

I will perform the tasks of conducting research and analyzing medical and scientific literature

Review and processing adverse events reported by investigators and provide medical and scientific information to health care professionals/Regulatory authorities

I will write concise, accurate and well-written case narratives. Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.

I will perform coding of diseases as well as adverse events according to the project-specific coding conventions. Process the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet.

To review the entire case, identify the key data elements as per SOP and find out the attribution between drug and event.

To assist in developing strategies for organizing and preparing regulatory and or commercialization documents like SOPs/Process charts.

I will help junior staff; undergo development and provision of training within specific areas of knowledge.

I will perform other activities as identified and requested by management.

ICON Clinical Research, Chennai, India

Duration: Aug 2013-Apr 2014

Designation: Drug Safety Associate

Job Roles:

Ensure a duplicate check is conducted against the Global Safety Database in accordance with SOPs for all ICSRs (Individual Case Safety reports) in order to determine whether there is an existing case file.

I will triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability

Review, assess, triage, process and report the adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within the specified time lines by meeting the quality standards.

Assessment of case reports for seriousness, case validation, causality and expectedness.

I will bookin/triage the cases initially after receiving from client and ensure expedited cases are processed within defined timelines of Regulatory authority & Business partners

I will manage the client safety inbox management and send required queries, distribute the cases when required and create an electronic case report file for a new case.

Experienced in reviewing and verifying the appropriate selection of SAEs from source documents for appropriate MedDRA coding.

Experienced in narrative writing for all types of reports (including literature, study, spontaneous and cases from health authorities)

Effectively maintain the safety database and corresponding entry guidelines, including accurate entry of data and ensure consistency between source documents and narrative summary.

Liaise with investigational site, reporter and/or Sponsor as necessary regarding safety issues and attend project team meetings and teleconferences as required.

Icon Clinical Research, Chennai, India

Designation: Admin Assistant (Medical)

Duration: Jul 2009- Aug 2013

Job Roles:

I will distribute Serious Adverse Event Reports to Sponsors, sites and applicable ICON personnel in accordance with standard operating procedures and SSP s.

I will Perform Daily entry into, and maintenance of, appropriate tracking systems for Serious Adverse Event (e.g. SAE tracking systems) and miscellaneous tracking logs for all studies.

I will handle SAE queries and other departmental queries as necessary; document records and keep for future filing.

I will distribute Exception Approvals, hospital records, and miscellaneous documentation to Sponsor contacts in accordance with Standard Operating Procedures and SSPs.

I will file all Medical Affairs and Drug Safety documents within allotted timeframes and upload it in the global safety database.

I will assist with organization and planning of meetings, including preparation and distribution of presentations, agenda and meeting minutes as requested.

I will handle mailing activities for Medical Affairs and Drug Safety.

I will distribute incoming mail and prepare outgoing mail including query/group mails.

Education:

B. Tech Industrial Biotechnology from Rajalakshmi Engineering College (2008-Anna University) Chennai, Secured 70%.

HSC in Kannada Sanga Higher Secondary School, Chennai, Secured 70%.

Skills in Clinical Research/Pharmacovigilance:

PG Diploma in Clinical Research - Annamalai University

Duration: 1 Year. (2009-2010)

Passed with First Class

Quintiles certified professional on Global GCP training “Clinical Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites”

Have knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.

In depth knowledge in safety reporting.

Clinical Research Project:

Topic : Adverse event reporting in Clinical Research

Co-Curricular Activities:

Presented Seminar on adverse event reporting at Annamalai University in Mar 2010.

Presented Seminars in the class during various semesters of under graduation.

Computer Skills: Completed Statistical Analysis Software (SAS) course in Zybeak Technologies, Chennai.

Other Skills:

Preparing charts, meeting minutes and meeting slides.

Have good knowledge in working with MS office and have good typing speed.

Extra-Curricular Activities:

Coordinated the Symposia conducted by our College in August 2005 and March 2006.

Actively participated in Fire and Safety training in Icon Clinical Research.

Hobbies:

Playing various games like Chess, Cricket, Table Tennis etc.,

Solving puzzles, Reading Newspaper etc.,

Personal profile:

Name : Raju Subramani

Date of birth : November 13, 1985

Address : No.296/8, Ganesh Colony, Konnur High Road Ayanavaram, Chennai. Tamil Nadu - 600023.INDIA

Marital Status : Married

Nationality/ Religion : Indian/ Hindu

Educational qualification : B.Tech Industrial Biotechnology, PGD in Clinical Research

Languages known : English, Tamil, Kannada & Hindi.

Declaration:

I acknowledge that the above furnished information is true to the best of my knowledge.

DATE :

PLACE : Bangalore S. RAJU

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