Management Medical

Career Summary:

In-depth knowledge of all applicable FDA/EMA/International/ICH-GCP safety reporting regulations and guidelines relating to Drugs, Biologics and Medical Devices

Achieve professional excellence in quality review of the processed cases and case processing activities

Execute pharmacovigilance safety management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, quality review, case follow up, report preparation and submission to regulatory authorities

Proficient in using global safety databases (GSD) ARGUS, ARGUS AFFILIATE, SEPTRE and SINA

Proficient MedDRA and WHO drug dictionary coder (4 years of experience in coding)

Worked on therapeutic areas such as oncology, cardiovascular, respiratory and endocrinology

Expert in quality review and processing of post-marketing, Clinical trial, Literature, Legal and Product Quality Complaint reports.

Handled safety database migration (SINA –ARGUS affiliate) as well as up gradation (ARGUS 4.2-7) responsibilities

Act as a Subject Matter Expert (SME) for case processing and quality review

Knowledge of aggregate safety reports including PSUR, PADER, and DSUR submission

Awarded with ‘OPEL’, ‘WAH’, and S.M.A.R.T. awards in recognition of my overall performance in Cognizant Technology Solutions and Sciformix technology Pvt. Ltd.

Experience in clinical trial monitoring and review of clinical trial documents

Quality oriented, with attention to detail, Excellent player with ability to work in a team environment

Excellent written and verbal communication skills

Proven interpersonal, analytical thinking, organizational and time management skills

Professional Experience:

DRUG SAFETY ASSOCIATE/ IN-LINE QUALITY REVIEWER (Apr 2014 – Sep 2015)

Sciformix technologies Pvt. Ltd,

Client: Johnson and Johnson

Database: SEPTRE, LCRx

Responsibilities:

Evaluation and medical review of clinical trial, post-marketing, literature, legal, product quality complaints for drugs and medical devices report for OTC (consumer) portfolio

To receive and process individual case safety reports for drugs and medical devices (ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports. This includes:

Triage of the received cases

Tracking of received ICSR

Entry of ICSR into SEPTRE

Medical coding

Generates concise, accurate and well-written case narratives

Query management and due diligence activities

Proficient in consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions using MedDRA, WHO drug dictionary and Company drug dictionary.

Responsible for CAPA writing, CAPA closure, audit and inspection readiness

Generated data listings from the safety database and assumes responsibility for accuracy of the data.

Assist pharmacovigilance centre in signal detection activities as requested by client

In addition to the above:

Management of data cleaning activities and SAE reconciliation projects

Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project.

Supports creation of the SAE/AE reconciliation plan and conducts SAE reconciliation in accordance with this plan and other project specific guidelines

Therapeutic area: Various (OTC products)

MEDICAL SPECIALIST (ANALYST)

Accenture Services Pvt. Ltd.,

Client: Pfizer (Oct 2013 – Feb 2014)

Database: ARGUS 7.0

Responsibilities:

Evaluation of pharmacovigilance case to determine the seriousness, expectedness, and therefore reportability of adverse events as per the SOP, WI and global regulatory guidelines

Processing and quality review of medical reports provided by data entry team

Ensure scientific and medical accuracy and completeness of pharmacovigilance reports before submission to regulatory authority

Responsible for CAPA management

Achieve excellence in case processing and quality review of literature cases

Therapeutic area: Multiple sclerosis

SR. DRUG SAFETY ASSOCIATE

Cognizant Technology Solutions,

Client: Novartis (Jun 2011- Sep 2013)

Databases: ARGUS (4.2 and 7), ARGUS affiliate and SINA

Management of ICSRs (individual case study reports)

Perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database, and provide feedback to case processing associate

Successfully manage team of newly recruits in terms of work allocation, query management, quality and compliance review

Associated with safety database migration activities (SINA to Argus affiliate) such as case review, data clean-up, reconciliation in new database and assisted UAT team in user acceptance testing

Performed CAPA writing and closure and participated in compliance management

Reconciliation of AEs and SAEs

Review and perform disease and medication coding

Perform data retrieval from the safety database

Support generation of aggregate safety reports (DSUR, PADER)

Monitoring and management of safety mailbox

Support development of Safety Management Plans (SMPs), Standard Operating Procedures (SOPs), and other procedural documents as needed

Support signal detection and risk management activities

Management of bolus case processing, non-case processing and SAE reconciliation

Participated in global safety database up gradation from ARGUS 4.2 to ARGUS 7

Support DS&E Projects and database validation activities as required

Therapeutic area: Oncology and Cardiovascular

CLINICAL RESEARCH ASSOCIATE

Deenanath Mangeshkar hospital and research Centre, (Feb 2010 – May 2011)

Conduct monitoring on the on-going in-house clinical trials and report patient safety related findings to ethics committee

To receive and review all documents such as new protocols, amendments and other study related documents such as SAE reports, informed consent etc

To assist the PI or any other competent authority for literature search and writing research proposal, manuscript, writing grand applications

Held responsibility for writing annual research report and SOP for monitoring

Assess the site infrastructure to find out about availability of space, equipment, trained manpower to handle particular equipment, ancillary facilities such as laboratories, pharmacy etc, and communication facilities.

To ensures that informed consent form sent by the sponsor is translated and back-translated into the local language as advised by the investigator

Worked on Oncology, cardiovascular and endocrinology clinical trials

Education:

M.S. in Regulatory affairs for drugs, biologics and medical devices (Sep 2015- To Present)

Northeastern University, Boston, MA

Post Graduate Diploma in Clinical Research (2009-2010)

Orange Institute of Clinical Research, Pune, MH (India)

Bachelor of Pharmacy (2004-2008)

North Maharashtra University, Jalgaon, MH (India)

Computer Proficiency:

MS Office Applications : MS Excel, MS Word, MS PowerPoint, MS Outlook

Operating Systems : MS Windows 2000/XP/Vista/7/8

Language Skills: English, Hindi, and Marathi

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