- Epidemiologist with experience of over 8 years in Regulatory and Drug Safety writing in multiple therapeutic areas coupled with proven track record in Pre-Clinical GLP Toxicology Research.
- Specialist knowledge in authoring/reviewing (End to End) CARs, PADERs, PBRER, PSURs, SURs, and SBRs, ACO, Ad Hoc Safety Reviews, SQR, RMPs, Clinical study narratives, Signal Detection - Literature Reviews, eCTD modules 2.4 & 2.5, Responses to Agency queries/assessments, Clinical trial protocols, rreports, and IBs.
- Specialist knowledge in handling (End-to-End) Pre-clinical GLP Pharmacology and Toxicology trials and Bio-statistics.
- Excellent Communication and Presentation skills, Good team player , Fast track learner and Executor, possess Analytical and Problem solving skills.
Deputy Manager - Medical Affairs (Role: Aggregate Reports Analyst)
August 2012 --- April 2017
Previous Position: Assistant Manager (Role: Regulatory and Safety Medical Writer) at Hospira, a Pfizer Company.
*Authoring and reviewing/QC the following PV documents for Global post marketing maintenance (Biosimilars and Generic drug portfolio) laising with corresponding global project teams: * EU (adhering to ICH E2C & GVP guidelines): PBRER, PSUR, SUR, and SBRs in Volume 9A format, ACOs, Ad Hoc Safety Reviews, and SQRs. * US (adhering to FDA guidelines): PADER. * Canada (adhering to Health Canada, ICH-E2C and GCP guidelines): CAR and IRSR. * Review of ICSRs. * Agency inspections and internal audits for PSMF (part of the team in passing EU PV audits). * Trained junior writers on various regulatory and safety documents. Signal Detection Activities (adhering to FDA guidelines & GVP Modules): * Critical appraisal of literature articles for various Drug safety documents for identifying new/potential signals. * Identification of pertinent signals from the ICSRs and part of SRC meetings for label updates. * Review literatures for establishing/refuting causal association between the event and drug. * Authored Position papers for product quality related issues.
MARKETING AUTHORIZATION PROCEDURES
Authoring and reviewing/QC documents pertaining to product development for MAA (EMA & FDA) laising with corresponding global project teams: * Investigational Brochures * Clinical trial protocols & reports * Clinical study narratives * eCTD – Non-clinical and Clinical Overviews (Modules 2.4 and 2.5) * Risk management plans (RMP) * Responses to regulatory queries/assessments.
Working knowledge of Argus, Track wise, MedDRA coding, Business intelligence, End Note, ISI Writer, MS Office suite, and Company specific plug ins for Medical writing.
Regulatory compliance, CAPA, trainings, global style rule book, process improvements and mitigation, and project management.
Senior research associate II - Pharmacology & Toxicology (Role: Study Director & Study Personnel)
February 2009 --- August 2012
RESEARCH AND DEVELOPMENT ACTIVITIES FOR IND APPLICATIONS VIVARIUM ACCREDITATION'S
*Instrumental (part of the team) for successfully achieving Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and Good laboratory practices (GLP) certification for lab animal vivarium. * Alternative Veterinarian in the Vivarium management adhering to AAALAC principles. TOXICOLOGY TRIALS (NEW CHEMICAL ENTITIES & MEDICAL DEVICES) * Study director for toxicology trials Acute, Sub Acute, Sub Chronic, Local, Systemic, Reproductive, Genotoxicity and Carcinogenicity studies of NCEs under OECD – GLP Compliance and Medical devices testing as per ISO:10993 guidelines. * Experienced in the preparation of Research proposal, SOPs, Trial protocol and Report, Statistical analysis of raw data (using SPSS, Graph Pad Prism, Stat Graph and Sigma Plot) and interpretation, and Archiving as per GLP compliance.
PHARMACOLOGY EFFICACY & SAFETY TESTING FOR IND FILING
*Handled end to end pharmacological efficacy and safety testing of NCEs (including pathology studies and cytokine assays with special reference to ELISA) in In vivo IBD/UC, CDAD, Asthma and COPD animal models. * Contributed for the IND filing of the company’s novel molecule. * Experienced in authoring White papers and posters of the pharmacology trials conducted for Company’s internal publication and Worldwide Scientific meetings.
* Experienced in drafting research proposal for testing a novel molecule to arrest the Phosphoinositide 3-kinase (PI3K) Signalling cascade for the treatment of COPD.
March 2006 --- September 2007
* Diagnosis and treatment (including surgeries) of small and large animals. * Sample collection and laboratory analysis (microbiology, pathology and parasitology). * Artificial Insemination (AI) in Large animals. * Vaccination and Preventive Therapy protocols for both Small and Large Animals. * Training farmers on the economics of livestock business management.
AdaptabilityAnalytical thinkingAssertivenessAttention to detailCoordinationInnovative thinkingResult OrientedTrust
Skills and Expertise
Analytical skills Analyze data Create SOPs Design case record forms Control data Interact with physicians Search literature on clinical trials Write papersClinical data collectionCoach and provide guidance to clinical staff.Collaborate with medical teamConduct animal studiesConduct literature searchesDetermine statistical analysis Ethics committee submissionsIdentify risksParticipate in medical reviewPrepare final reportPrepare internal auditsPrepare investigator brochuresPrepare regulatory documentsPrepare responses to health authority queriesProvide benefit risk assessmentReview clinical study reportsReview medical reportsStatistical analysisValidate dataWrite combined statistical and medical reportsWrite documentsWrite final reportsWrite medical reportsWrite papers
Master's degree in Infectious diseases - Epidemiology and Preventive Medicine from Royal Veterinary College, U. of London in 2008
PGDM in All gamuts of Organizational management from Singapore Institute of Management in 2007
BVSc & AH in Veterinary Medicine from Tamil Nadu Veterinary and Animal Sciences University in 2006
in Science, Social, Maths and Languages from Bharathi Vidhya Bhavan in 2000
Training and Certification
Corporate Training Program on Regulatory Medical Writing Certification
Lean Six Sigma Green Belt Certification