ARGUS
Anu George
Pharmacovigilance Specialist & Regulatory Literature Information Specialist: Having Pharmacovigilance Experience Of 4 Plus Years (Pharmacovigilance/Drug Safety) As Drug Safety Associate And Senior Pharmacovigilance Associate And Currently Working As Regulatory Information Specialist (literature) With 2 Plus Year Experience. Extensive Experience In Case Triage, Case Creation, Case Processing And Quality Review (Pharmacovigilance/Drug Safety). Experience In Literature Search, Strategy Creation, Literature Review, And Literature Screening.
Sai, Puppalaguda, Hyderabad,TG
Summary
Pharmacovigilance experience of 4 plus years (Drug safety) and currently working as Regulatory Literature Information Specialist with 2 plus year experience in Novartis. Extensive experience in case triage, case creation, case processing and quality review . Experience in literature search, strategy creation, literature review, and literature screening. Motivated to learn, grow and excel in Pharmaceutical Industry.
Overview
4
4
Languages
1
1
Certification
8
8
years of post-secondary education
7
7
years of professional experience
Work History
Regulatory Information Specialist
Novartis
Hyderabad, Telengana
07.2018 - Current
- Support regulatory and patient/drug safety (pharmacovigilance) teams by researching the product, strategy alert creation, performing search and reviewing of literatures of the products for safety signal monitoring (ICSR, PSUR, DSUR) and annual report submissions (NDA/IND).
- Effective researching of product terminology/drug nomenclature, drug class hierarchies and competitors.
- Product database knowledge: OVID, Embase.com, Pharma projects, Cortellis, Medline, Biosis, Pharmapendium, Causaly, Micromedex
- Effectively construct precise drug literature search strategies.
- Understanding of medical terminology.
- Proficient in alert strategy creation.
- Performed comprehensive review of literature and analysis of scientific and technical published literature to support health agency requests, product submissions, formulary reviews etc.
- Advanced bibliographic expertise and information management.
- Proficient in citation management tools, i.e. End Note.
- Exceeded to meet deadlines and handled multiple projects.
- Effectively correspond – written and oral, with scientific/medical associates.
- Mentored new hires, resulting in stronger staff development and increased productivity.
- Amended SOPs and guidelines
Senior Pharmacovigilance Associate
Apcer Pharma
New Delhi, New Delhi
03.2016 - 07.2018
- Quality Review of ICSRs in Pharmacovigilance database (ARGUS).
- Review of Source data entered by data entry person.
- Make corrections, if major, route the case back to DE.
- Screening and review of literature articles and the assessment for identifying valid ICSRs.
- Preparation of ANDA report.
- Data Entry and Triage of ICSRs (as required).
- Maintain awareness of changes to/new regulations affecting PVG activities.
- Execution of company Standard Operating Procedures.
- Builds and maintains good relationships across functional units and company affiliates.
- Compliance to project guidelines.
- Trains and mentors new employees in PVG.
- Eliminated downtime and maximized revenue by providing top project quality control.
- Developed and maintained courteous and effective working relationships.
- Worked flexible hours; night, weekend, and holiday shifts.
- Used Microsoft Word and other software tools to create documents and other communications.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Trained staff and updated training documents to meet regulations and standards.
- Read scientific literature and bibliographic sources.
Drug Safety Associate
Accenture Pvt Ltd
Chennai, Tamil Nadu
03.2014 - 02.2016
- Taking care of rapid and timely processing of initial and follow-up individual case safety reports of adverse events or serious adverse events or suspected unexpected serious adverse reactions from spontaneous, literature or solicited or social media or health authority sources based on conventions and rules in the global safety database (ARISg).
- Case Registration (Triage) based on seriousness and type of cases.
- Responsible for data entry, MedDRA coding, and label assessment of the adverse events in SUSAR cases.
- Performs duplicate check in the database for the case.
- Analyze the source documents and enter the data into the respective fields in the database.
- Coding of suspect drugs using Company Product Dictionary-CPD and WHO Drug Dictionary.
- Partly responsible for timely reporting the adverse events and side effects to health authorities.
- Contacting reporters of the adverse events to obtain complete information for analysis.
- Assisting with the preparation of the audit/inspection and participating in the audit/inspection when appropriate, 6 months in Clinical Research Department at Torrent Research Centre, Ahmedabad as project trainee.
- Trained in preparation of protocols and overview for BA/BE study.
- Trained in preparation of ANDA report.
- Exposure to BA/BE study.
- Reviewed, compiled and analyzed data for safety database management.
- Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
- Assessed and distributed pharmaceutical product adverse event documents.
- Supported inspections, visits and audits as well as CAPAs management.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Oversaw adverse events case reporting and conducted follow-up.
Education
M. Pharm - Pharmacology
KMCH College of Pharmacy Coimbatore
Coimbatore 08.2011 - 10.2013
B. Pharm -
Dr. M.G.R Medical University
Chennai 08.2007 - 06.2013
Skills
Protocol development
Certification
Certificate of completion of Basic Program in Pharmaceutical Medicine by Novartis
Accomplishments
Presented a poster entitled “Study on prescription pattern of COPD in the pulmonary department of the tertiary care hospital” during national conference on “preclinical and clinical challenges in drug discovery” organized by Kovai Medical Center and Hospital, Coimbatore, on 10th & 11th November 2011
Orally presented a scientific paper entitled “Investigation of antiarthritic, anti- inflammatory and analgesic activities of Tephrosia purpurea extracts” during “International congress of pharmacy graduates” organized by southern region pharmacy graduates held on 6th & 7th October 2012.
Affiliations
Member of Indian Pharmacy Council
Registered Pharmacist
Additional Information
PROFESSIONAL ASSOCIATIONS:
Seminar Attended:
National seminar on “Recent Trends in Pharmacy” organized by Amrita School of Pharmacy On 5th December 2008 AIMS, Kochi.
International seminar on “Emerging Trends in Pharmacy Practice” organized by Amrita School of Pharmacy on 20 February 2009 AIMS, Kochi.
62nd Indian Pharmaceutical Congress 2010 held at Manipal University on 17-19 December 2010.
National conference on “preclinical and clinical challenges in drug discovery” organized by Kovai Medical Center and Hospital, Coimbatore, on 10th & 11th November 2011.
National conference on “Experimental Pharmacology and Drug Evaluation” organized by PSG College of pharmacy, Coimbatore on 7th and 8th June 2012.
Software
ARISg
Ovid
Embase
Medline
Pubmed
MS office
Interests
Reading
Dancing
Timeline
Regulatory Information Specialist
Novartis
07.2018 - Current
Senior Pharmacovigilance Associate
Apcer Pharma
03.2016 - 07.2018
Drug Safety Associate
Accenture Pvt Ltd
03.2014 - 02.2016
M. Pharm - Pharmacology
KMCH College of Pharmacy Coimbatore
08.2011 - 10.2013
B. Pharm -
Dr. M.G.R Medical University
08.2007 - 06.2013
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