Ankita Sharma

ANKITA SHARMA Flat No-602, Garden Estate, Pokhran road-2, Thane. Maharashtra E-mail:-,-Mobile No: - JOB OBJECTIVE To associate & contribute to the emerging field of Pharmacovigilance / Safety Monitoring/ Clinical Research in Pharmaceutical MNCs/ Clinical and Contract Research Organizations / Other Research Organizations and over all drug safety in pharmaceutical industries by utilizing the experience and knowledge gained, also aiming for self growth along with the growth of the organization. PROFESSIONAL PROFILE Placed as Pharmacovigilance Officer: From Jul.2009 to Jul.2010- -Pfizer Process in Wipro, Greater Noida Placed as Assistant Health Writer: From Aug. 2010 to Feb.2012- - Via Health and Communications Pvt. Ltd., Noida Placed as Research Scientist: From Mar.2012 to Sep. 2013- Jubilant Clinsys, Noida Placed as Data Analyst: From Oct. 2013 to July 2014- Cognizant Technology Solutions, Mumbai Working as a Senior Medical Writer: From August 2014 till date- Siro Clinpharm Ltd. RESPONSIBILITIES Siro Clinpharm (Aug.2014 – till date) Preparing development safety update reports (DSURs) & suspected unexpected serious adverse reaction reports (SUSARs) collecting, organizing, analyzing and presenting the available data in line with organization’s templates, Line listings & procedures and Health Authorities assessments. Involved in writing and compiling complex documents across different therapeutic areas (TAs) Identification of safety signals, adverse drug reactions (ADRs) and analyzing benefit-risk assessment for the reports Participate in the development and maintenance of safety documents’ templates and Standard Operating Procedures pertaining to safety aggregate reports Perform peer review and QC for the safety documents QC performed for Risk Management Plans (RMP) Entering and putting the CSR and protocol information related to clinical trial on the client’s database (Web ToS) Preparing/drafting Manuscripts, Abstracts and Posters for Clinical Studies Cognizant Technology Solutions (Oct.2013 – Jul.2014) Preparing US periodic adverse drug experience report (USPRs), Annual Product Review (APR’s) Peer review of documents written by fellow writers as a part of internal QC Followed Novartis specific documentation, Novstyle Worked as a shared resource for drafting periodic benefit risk evaluation report (PBRERs) Jubilant Clinsys (Mar.2012 to Sep. 2013) Prepared regulatory documents like Protocols, Informed Consent Documents (ICD’s) for BA/BE studies Worked on Investigator’s Brochure (IB) Responsible for setting pharmacovigilance and adverse event reporting system in safety database VIGIS3 Receive information on adverse events, perform initial checks, search database to prevent duplicate entries Performed QC on periodic safety reports (PSURs) Via Health and Communications Pvt. Ltd (Aug. 2010 to feb.2012) Prepared health articles for different pharma organizations to prove labelling of products safety and efficacy Performing extensive Literature search from renowned Journals and published studies Proficient in search engines & different databases like Embase, TRIPS databse, Medline, Best Bets, Cochrane Wipro Pvt. Ltd. (Jul.2009 to Jul.2010) Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file (triaging ICSRs) and initialize received drug safety reports in the tracking tool and ARGUS safety database Assessing the seriousness and non-serious criteria Evaluate and finish processing of non-expeditable AEs reports, including review for complete-ness and accuracy Prepared Safety narratives and summarizing the essential details of the case ABSTRACT IN CONFERENCES 2nd CDRI-NIPER (RBL) Symposium on Medicinal chemistry & Pharmaceutical Sciences Antimicrobial and Antioxidant activity of Stevia rebaudiana Evaluation of ethanolic leaf extract of Achyranthus aspera for its Analgesic activity Memory improving actions of Spilanthes acmella Murr. flower in rats: possible involvement of Acetyl cholinesterase inhibitory mechanism EDUCATIONAL QUALIFICATION Name of the Examination Name of the Board / Institution Year of Passing Div. / Class M. Pharm Biju Patnaik University of Technology, Rourkela 2009 1st (78%) B. Pharm Uttar Pradesh Technical University, Lucknow 2007 1st (66%) Higher Secondary Agra Public School, Agra 2002 1st (70%) High School St. Conrad's Inter College, Agra 2000 1St (60%) PERSONAL PROFILE DATE OF BIRTH : 28th November 1983 SEX : Female MARITIAL STATUS : Married LANGUAGE KNOWN : English, Hindi Hobbies : Reading, Driving ANKITA SHARMA