Medical Safety

PROFILE OF QUALIFICATIONS

Global work experience spanning 4 years in pharmacovigilance (medical writing) and over 3 years in clinical practice. Career achievements and skills: Familiar with Pharmacovigilance, clinical and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations such as 21CFR312.32, 21CFR314.80, 21CFR600.80. Strong understanding in case processing, scientific writing and review, expedited reporting rules (ICH E2A Guideline), signal detection and safety software concepts.

Scientific writing and review - USA, Europe, Canada, Asia

Prepared and reviewed medical context and medical chronology of safety narrative and safety reports for adherence to SOPs, regulatory requirements and pharmacovigilance adverse event reporting. Co-authored regulatory aggregate reports (PSUR, DSUR, AR). Familiar with signal detection and risk management plan. Reviewed global reports from solicited (clinical trials, registries and post-market studies) and unsolicited (spontaneous reporting) sources and provided company assessment.

Pharmacovigilance medical writing and Case processing - USA, Europe, Canada, Asia

Performed triaging and accurate data capture for individual case safety reports (ICSR’s). Assessed dechallenge-rechallenge, company causality, seriousness and labeling as per IB, CDS, EU and US regulatory requirements. Drafted drug safety sections of various regulatory and safety documents for potential signals or issues (product quality). Assisted in signal detection by identification of SUSAR, targeted and Issue events. Performed clinical trial unblinding and reconciliation activities.

Clinical Practice (Dentist)

Conducted all aspects of patient care, including; detailed history, physical examination, implemented treatment plans, prescription of medicine and in-office minor surgical procedures.

EDUCATION

M.S. in Regulatory Affairs for Drugs, Biologics and Medical Devices April 2016 – present

Northeastern University, Boston, MA

Courses completed: (GPA: 3.77)

Human Experimentation: Prepared informed consent form compliant to 21 CFR 50.

Regulatory Writing-New Drug Applications: gained experience from the program with preparing a full FDA Meeting Request submission as a hypothetical IND amendment, prepared cover letter and fast track designation.

Advanced Writing on International Biomedical topics: gained experience in writing on international medical topics. Submitted a paper on International biomedical topic: “Inspite of smoking ban: The percentage of oral cancer is increasing in India”.

Drug and Medical Device Regulations: gained experience in a regulatory strategy demonstrating how to introduce a drug and a device to commercial market using an appropriate regulatory path (IND, NDA, IDE, 510(k), premarket notification, PMA etc.

Medical Device development-Regulatory Overview: gained experienced in regulatory writing communications skills by submitting complex regulatory information in a brief and concise manner.

Regulatory Affairs Strategic Planning Management: gained experience regarding responsibility for the identification of organization's business needs and documentation in association with other functions like IT Operations.

Bachelor in Dental Surgery (BDS) September 2003- September 2009

V.S.P.M’s Dental College and Research Center, India

(Scholarship holder by Government of India)

Gained experienced in conducting mass practices in general dentistry including pediatric, restorative, endodontic, conservative, prosthodontic dentistry and minor maxillofacial surgeries.

WORK EXPERIENCE

Scientific writer (Data Analyst) February 2014 – November 2015

Cognizant Technology Solutions, Mumbai

Client: Boehringer Ingelheim Pharmaceuticals

Joined as a scientific reviewer and trained newly joined associates for the case review. Helped to stabilize the process by streamlining intricate case processing conventions and significantly improving all key performance indicators (KPIs) to earn client’s appreciation and management’s recognition in the form of award for good production and quality. Responsibilities included –

Reviewed safety narrative of post marketing studies and clinical trial deaths, serious adverse events and designated medical events for medical integrity of the case and writing concise narratives and company assessment.

Assessed ICSRs for multiple therapeutic areas for seriousness, causality and labeling/listedness/expectedness (IB, CDS, EU-SPC and JP), AE coding using MedDRA.

Reviewed spontaneous, clinical trial, compassionate, patient registries, health authority, literature, license partners and litigation cases in global safety database processed by operations through random audit and provided feedback to the associates accordingly.

Generated data listings from the global safety database and assessed the reportability of ICSRs.

Submitted safety reports to the Regulatory Authorities, while documenting all internal and external communications

Co-authored, along with the Medical Safety Physicians, all safety sections for various aggregate safety reports (e.g. DSUR, PBRER/PSUR).

Provided support for signal detection and the Risk Management Team.

As a Team leader Assistant, provided RCA and implemented CAPA for authority.

Contributed to the review of all findings related to drug safety activities from audits/regulatory inspections (internal company and PV TPs).

All client interactions (Global joint safety committee meetings, operation call, reconciliation process).

Prepared the team for and presided over audits, mentored quality reviewers and data entry associates.

Pharmacovigilance Scientist May 2012 – February 2014

TATA Consultancy Services Ltd, Mumbai

Client: Roche Pharmaceuticals

Gained experience in case processing before becoming recognized as a quality reviewer. Within two months of being promoted, significantly improved KPI’s with zero noncompliance, and 100% quality. Responsibilities included-

Identified potential SUSARS, invalid case reports, special situations, duplicates and performed mergers as per the aligned SOPs.

Contributed to and drafted safety sections of various regulatory and safety documents including summaries of safety and efficacy, clinical overviews, signal and risk evaluation, other safety narratives and Informed Consent Forms.

Performed accurate data capture for ICSR which may include SUSAR, SAEs, AESI, ADRs and DI reports along with appropriate clinical assessment inclusive of company causality, seriousness and labeling as per IB, CDS, EU and US regulatory requirements and writing concise narrative.

Handled ICSRs via E2B or data exchange systems along with acknowledging receipts to the sender.

Reviewed coding of events, suspect drug, lab data, concomitant and past medication and data retrievals from the global safety database.

Interacted with study data manager to post queries to clinical database or directly with clinical study sites to obtain any critical or missing case information and initiated requests for case follow up for clinical trials and post marketing adverse events.

Assisted in signal detection by identification of SUSAR, AESI, targeted and Issue events and generating follow-up request or guided questionnaires as needed for drugs as per the requirement of clinical trial protocols and well versed with clinical trial unblinding.

Assisted with clinical trial reconciliation, as well reconciliation activities associated with safety data exchange & Pharmacovigilance Agreements.

Dental Practitioner March 2009 –April 2012

Dr. Mihani’s Multispeciality Dental Clinic

Treated problems affecting the oral mucosa, such as mouth ulcers and infections.

Treated patients with root canal treatment.

Knowledge in pain control and trained in anesthesia.

Extracted impacted, mutilated and non-restorable teeth.

Conducted Public health programs for oral submucous fibrosis and oral cancer patients.

Internship September 2008 - September 2009

V.S.P.M’s Dental College and Research Center

Taken patient’s history with thorough examination and investigations that aid in arriving at a diagnosis.

Patients with required alterations in medications and other medical advice.

Technically well-qualified in taking radiographs and ability to glance at a radiographic image and immediately providing an accurate interpretation.

Served as the clinical provider on weekends and holidays, have participated in a community based program to spread awareness about oral cancer and joined in an effort to provide free physical examinations to the uninsured.

SKILLS

Regulatory Skills

Comprehensive knowledge of US FDA regulations, EMA regulations and ICH guidelines.

Ethical issues involved in clinical trials and clinical protocol (ICH E6 and E8), IRB requirements (21 CFR 56), Change Control Management.

Pharmacovigilance adverse event reporting, aggregate reporting, annual reports, PADER, PSUR and DSUR.

Regulatory submissions: IND/NDA/ANDA/BLA/510k/PMA.

Working knowledge of MedDRA, company drug dictionary and WHO drug dictionary.

Overview of Premarket approval, submissions, Methodical understanding of regulatory requirement for the initiation and conduction of clinical trials, understanding of 21 CFR, GMP regulations, SOP handling, Risk management, RCA, CAPA, Complain handling.

Software Skills

Drug Safety Software: MedDRA, ARISg, Argus

Others: Microsoft Suite (Word, Excel, PowerPoint, Access, Outlook)

Language Skills:

Proficient verbal and written skills: English, Hindi, Marathi

Core Competencies:

Enhance self-awareness about changing regulatory requirements and remain abreast regarding the change

Regulatory Affairs policies in the pharmaceutical industry

Organizing, Planning, and Time management

Establishing and maintaining Interpersonal relationships

Making Decisions and Solving Problems

Internal and international Audit handling.

ACADEMIC SEMINARS

Participated in mastering the Endodontics-Basic and Advanced course.

Presented paper on types of occlusion and temperomandibular joints.

CERTIFICATION

Obtained certification in medical coding (MedDRA).

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