Safety Data Entry
Resume:
Devyani Grewal
Goodison Avenue
Mississauga
*************@*****.***
CAREER OBJECTIVE:
To be an astute learner and to pursue a highly rewarding career in an organization which has healthy work environment of innovation and excellence where I can work with devotion and utilize my skills and knowledge efficiently for personal as well as organizational growth.
CAREER ABSTRACT:
More than three years of Pharmacovigilance experience with strong analytical skills and a broad range of computer expertise. Skilled at presenting pharmaceutical concepts and issues in a clear and concise way.
CORE COMPETENCIES:
Comprehensive knowledge of pharmacovigilance principles and regulations. Expertise in
handling of adverse event reports and quality review of Individual Case Safety Reports (ICSRs). Skilled in data entry for all serious and non-serious cases. Good understanding of compliance monitoring, research process for drug/clinical trials, in-depth knowledge of international drug safety and coding principles, submission criteria and regulatory timeline requirements. Excellent analytical, problem-solving and time management skills.
PROFESSIONAL EXPERIENCE
PAREXEL International, Chandigarh, India Since 21-Apr-2014
Website: https://www.parexel.com
Company Profile: Pharmacovigilance
Designation:
Pharmacovigilance Analyst: from Apr-2015 – Dec-2017
Pharmacovigilance Scientist: from Apr-2014 – Mar-2015
Pharmacovigilance experience key areas:
Expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) which include:
oTriage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
oConducting duplicate searches prior to registration and identifying potential duplicates
oManaging duplicate cases appropriately
oData entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc.),
oWriting case summaries, assessing causalities if required and writing company comment if required
oData validation i.e. crosses checking against source documentation.
Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”
Expertise in managing safety data on various safety databases
Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client procedures and international drug safety regulations including
oICH guidelines on safety and efficacy
oNew EU PV legislation
oFDA guidelines
Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Expertise in handling the ERP systems (Enterprise Resource Planning).
Performing Quality Control (QC) of cases for the accuracy of data captured on the client's database per relevant guidelines and procedures.
Monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated Corrective and Preventive Action (CAPA) plans, as applicable.
Query management.
Interacting with designated client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies.
Responding to clients/customers in a timely manner
ACADEMIC QUALIFICATIONS
Completed MSc BIOTECHNOLOGY in Merit from THE UNIVERSITY OF MANCHESTER, United Kingdom. (2011-2012).
Qualified DELF A1, DELF A2 and DELF B1. Standard exams in French after completion of level 1 to 5. (2009-2011)
Completed (Post Graduate Diploma In Computer Applications) PGDCA with Grade A from DOEACC Society CHD (Autonomous Scientific Society of Department of Information technology, Ministry of Communications & Information technology, GOVT of INDIA) (2008-2009)
Pursued B.Sc. (HONS) BIOTECHNOLOGY, PANJAB UNIVERSITY, CHD, India (2005 to 2008).
Research Projects experience
Handled a project in Preparation of Hydrogels and Drug Delivery at University of Manchester (United Kingdom) from Sep 2011-Sep 2012.
A two weeks project in Immunological Techniques at Orbit Biotech, Mohali (www.obitbiotech.com).
A four weeks project in Upstream and Downstream Processing at Bioage, Mohali (www.bioageindia.com).
Prepared a project report on Enzyme Glucoamylase (its optimisation and immobilisation). Elaborate experimentation done at college laboratories for the same from May 2007-Jun 2008:
Achievements
Given presentations at various University Workshops at United Kingdom’s University meets
Been vice-president of intra cultural student success promotional club.
Qualified GRE-2009.
Participated and awarded for various dramas in French and English
Best choreo staged in GENETECH 2006-2007.
REFERENCE AVAILABLE ON REQUEST
Immigration Status: Permanent Resident
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