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 :
** MASTER OF PHARMACY (PHARMACEUTICS).
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.
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