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Drug Safety Associate Resume Sample, Experience : 2 years



Name of the Candidate:Sachin Thawkar
Name of the Post Applied:Drug Safety Associate
Job related skills / software:Accountable for handling ICSRs received via data exchange systems, disposition of valid items into ARIS from IRT for further processing in ARIS.
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:2 years
Salary Expected per Month(Rs):40,000 to 50,000
Highest Qualification attained:M.Pharm. : Master of Pharmacy
Major / Specialization:Pharmacovigilance
Email Id:sachin.thawkar004 AT gmail.com
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :


Sachin Thawkar
Sachin.thawkar004 AT gmail.com
O-306, Om Prasad CHS, New Rachana Park, Chakki Naka, Tisgao, Kalyan (East) Maharashtra (India) Zip code  : 421307

Career Objective  :
To secure a position with a reputable company in which I can exercise my knowledge gained during my professional experience.

Job Level  :
Passionate pharmacovigilance & drug safety professional with comprehensive experience in Individual Case Safety Reports (ICSRs) for more than 2 years of experience as drug safety associate.

Knowledge of Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experiences Report (PADERs).

Professional Experience  :
Working as Senior Drug safety Associate (Mentor) at Tata Consultancy Services from 08/Oct/2013 to till date for Roche Pharmaceuticals.

Job Role  :
** Accountable for handling ICSRs received via data exchange systems, disposition of valid items into ARIS from IRT for further processing in ARIS.
** Acknowledging receipt of ICSRs to sender within the timelines documented in the relevant SOP.
** Handling invalid items in IRT appropriately through reference to SOPs, relevant training and the ARIS user manual.
** Conducted complete case review of all domestic and foreign reports for all pharmaceutical products including clinical SAE reports of investigational products received from clinical trials and spontaneous AE/SAE reports of marketed products received via call center/literature searches/etc.
** Follow case processing management of Clinical Case Reports and Spontaneous Individual Case Safety Reports.
** Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labelling and company causality for each adverse event)
** Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions.
** Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP.
** Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up information.
** Identified and handled Suspected Unexpected Serious Adverse Reaction reports (SUSARs) for Investigational Medicinal Products (IMPs) and Comparators.

Managed training of new recruits  :
** Trained resources for Drug Safety and Case Processing for handling the job role of Drug Safety Specialist.
** Create and maintain workflow trackers, flow charts, Power Point slide presentations as needed.
** Hands-on experience in MedDRA and knowledge of ICD coding & various Thesaurus Management Systems.

Core Competencies  :
** Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.
** Knowledge of 21 CFR Parts 11/314/20, Volume 9 A, MHRA best practices, CIOMS guidelines and ICH recommendations.
** Extensive knowledge of drug safety and drug development process and procedures.
** In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines.
** Possess sound communication skills, both in verbal, and written.

Technical Skills  :
ArisG Safety Database Proficient knowledge of MS office.

Education  :
Nagpur University, Maharashtra (India)
** BACHELOR OF PHARMACY Nagpur University, Maharashtra (India)

Key Strengths  :
** Ability to work in a team.
** Determination towards work.
** Positive attitude towards life
** Capacity to deal with stress.
** Willing to relocate

Personal Profile  :
Date of Birth  : Sep 24th 1989.
Hobbies  : Watching TV & Reading Books.
Languages Known  : English, Marathi, and Hindi.

Declaration  :
The above information is true to the best of my knowledge.

Date  :
Place  :


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