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Drug Safety Associate Resume Sample, Experience : 2 years

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Name of the Candidate:Sachin Thawkar
Name of the Post Applied:Drug Safety Associate
Job related skills / software:expertise in ICSR case processing
Sub Category:Pharmacovigilance
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:B.Pharm
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@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.
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• 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 and reading books. Languages Known : English, Marathi, and Hindi. The above information is true to the best of my knowledge. Date: Sachin Thawkar


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