Career Objective :
To seek a Challenging Career that tests my mettle and brings out the best in me and to be a member of a team that excels in working towards the growth of the organization.
Academic Profile :
** Master of Pharmacy in Pharmacology with an aggregate of 75 % from Rao's College of Pharmacy, Nellore during 2011-13.
** Bachelor of Pharmacy (2007-2011) with an aggregate of 77.16 % from Rao's College of Pharmacy, affiliated to Jawaharlal technological University, Anantapur.
** Higher Secondary Education (2005-2007) from Board of Intermediate Education with an aggregate of 93.4% at Sri chaitanya Junior College, Tirupathi.
** Secondary School Education, State Syllabus (2005) with 90% at Shantinikethan High School, Mydukur.
Professional Career :
Internship :
** Worked as Pharmacovigilance Intern from Jul 2012- Oct 2012 in Synowledge PV Services, India Pvt Ltd.
Employment :
** Since May-2016 - Oparations specialist at Quintiles Technologies Pvt. Ltd. Responsible to perform triage activities, following company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate polices
** Since Oct 2012-to May-2016 Drug Safety Associate at Synowledge India Pvt Ltd (Bioclinica).
Responsible for quality review of case cases, following company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate polices.
As case Intake Member :
** Responsible for case intake, duplicate check and registration
** Maintain log of source documents and other communications
As Case Processor :
** Responsible for data entry of individual case safety reports into database
** Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures
** Process all incoming cases in order to meet timelines
** Full data entry including medical coding and safety narrative
As medical coder :
** Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g. MedDRA, company product dictionary, WHO-DD)
As a narrative writer :
** Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
As Quality check reviewer :
** documents as per applicable SOPs, work instructions and client guidelines
** Train data entry team in order to ensure highest quality
** Provide the feedback to the data entry team members for the errors noted and quality improvement of the process
** Responsible for CAPA writing
** Responsible for late case analysis
As Literature Review Specialist :
** Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
** Review of literature articles to identify case safety reports.
** Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
** Assist in signal generation and safety analysis activities.
** Ensure quality of literature searches and reporting.
** Review of local/global literature reports to determine regional reportability.
** Create/maintain study summary documents.
** Assist with narrative writing for periodic/ad hoc submissions.
** Assist with ad hoc or routine safety monitoring activities.
Therapeutic areas covered in Pharmacovigilance :
** Central Nervous System, Endocrinology, Rheumatology, Immunology, Anti-Cancer and Diabetes
Types of cases handled :
** Serious Spontaneous
** Non-serious Spontaneous
** Review of Serious Literature
** Review Non-serious Literature.
** E2B cases
** Legal cases
** Clinical trial cases
** Pharmacovigilance database/systems experience
** IRT [Inbound Receipt Triage], AGXchange
** ARISg 6.0
** ARISg 7.0
** SCEPTRE
Other responsibilities :
** Following up with sites regarding outstanding queries
** Follow up on reconciliation discrepancies
** Follow departmental AE work flow procedures
** Closure and deletion of cases
** Perform any other drug safety related activities as assigned
** Perform literature review activities when trained and assigned.
Skills & Expertise :
** Pharmacovigilance
** MedDRA
** Clinical trails
** ICH-GCP
Computer Skills :
** Proficient in Windows xp or later
** MS office (MS word, Excel, Power point)
** Statistical analysis using Graph Pad Prism v5
Strengths :
** Maintaining good interpersonal relationships.
** Willingness to work and ability to adapt to the situation.
** Ability to work in a team efficiently.
Academic Projects :
** Industrial Training : Undergone PRACTICAL TRAINING in sections of Tablets, Liquid orals, Capsules, Manufacturing, Packaging Area and Quality Control Department at Granuls india Pvt.Ltd, Hyderabad.
** Project (B.Pharm) : Gastro retentive drug delivery systems of ofloaxacin.
** Project (M.
Pharm) : Anti-ulcer and analgesic activity of ethanolic extract of Annona Squamosa leaves.
Declaration :
I hereby declare that the above information is true and correct to the best of my knowledge.
Place : Bengaluru
Date : (S RAMADEVI)