Career Objective :
To be a part of an organization where the management structure recognizes and rewards loyalty, honesty, hard work and ambition of an employee by providing growth opportunities and necessary infrastructure that could contribute to the success of the company.
Job Responsibilities :
** Quality review of ICSR
** Preparation of SDEA agreement with multiple Pharma company
** Handling of PADER, PSUR and RMP
** Preparation of risk management plan.
** Knowledge of Regulatory affairs
** Performing MedDRA coding assessment.
** Assessing causality for safety cases reports.
** Perform expectedness and listedness assessment and ICSR report ability.
** Generate follow-up questions for the cases.
** Conduct quality review of ICSRs
** Distribution of ICSR for submission when required.
** Respond to queries from clients as required.
** Perform document management, including scanning and filing of source documents.
** Contribute to maintenance and compliance on adverse events reporting
** Escalates to Project Leader for quality callss and requests for Health Care Professional consultation involving safety issues.
** Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for pharma and clinical trial drugs.
** Tracking and initialization of single case drug safety reports in the safety database.
** Accurate data entry and coding of adverse event reports.
** Standard operative procedures and regulatory requirements.
Relevant Work Experience :
Project :
1.Working at Tata consultancy services as a Pharmacovigilance scientist level-I (From Apr 2012 to 07 Apr 2014 as Pharmacovigilance Scientist I.
2. Working at Cognizant Technology Solution (From 14 Apr 2014 to 15 Apr 2016 as Medical Safety Specialist).
3. Inventia Healthcare Solution (Core Pharma Company) From 18 Apr 2016 to till Date as Regulatory officer in Pharmacovigilance. (More than total 4.0 year of experience).
Academic Summary :
** S.S.C 2003 Wees English high school [Thane] Mumbai university
** H.S.C 2005 GVM Junior college [Thane] Mumbai university
** Diploma in Pharmacy 2008 SAS college of pharmacy. Mumbai university
** Bachelor in Pharmacy 2011 Dr L.H.
Hiranandani college of pharmacy. [Ulhasnagar] Mumbai university
Strengths :
** Can easily adapt to the new trends and ideas.
** Flexible in working at any location.
** Experience of working on Pharma industry and BPO/KPO industry.
Key Skills :
** Single ICSR processing.
** Can process all clinical, spontaneous, non interventional and Legal cases.
** Basics of pharmacovigilannce.
** Attending Client calls
** Knowledge about MedDRA and ICD
** Good knowledge of MS Excel, MS Word and power point.
** Ability to Handle Team
** Performed Back up TL role
** Quality review of ICSR Areas of Exposure
** Excellent in processing all types of single ICSR reports.
** Excellent in processing all Clinical, spontaneous, interventional and non-interventional studies/programme reports and Legal case processing (Arisg database)
** Knows role of Investigator, monitor, auditor, DSA, CRC and regulatory authorities.
** Excellent negotiation, interpersonal and communication skills
Certifications :
** Certified in Advance Excel.
** Certified in MS CIT [62%].
** Participated in Patient Counselling Competition during the National Pharmacy Week organized by IPA.
IT Skills :
** Knowledge of MS word, MS power-point, MS excel.
** Knows MS word including Mail merge, Macros and other functions of MS word.
** Knows MS excel including conditional formatting, sorting and filtering, pivot table, charts, hyperlink, macros, formula and functions.
Extra-Curricular Activities :
** Active member of college cultural team and sports team.
** Participated in many dance and fashion show at inter college level.
** Play Football, Volleyball, Cricket, Carom, T.T., chess etc.
Personal Details :
Date of Birth : 10th Nov 1986
Marital status : Married
Address : 202/B-6, Saivihar complex, kharegaon, kalwa, Thane (W)
Linguistic Abilities : English, Hindi and Marathi
Declaration :
I hereby declare that all the information furnished above by me is true to the best of my knowledge.
Date : 01 May 2016
Place : Thane, Mumbai