Dr. Shivani Prasad Khasnis C* ***/*** Lake Town, Katraj, Pune-411037

Phone: 0091-976-***-**** / 0091-202-***-**** Email: acw1df@r.postjobfree.com SYNOPSIS

- A Clinical Researcher with 9 years of experience and a strong academic background.

- Extensive experience in Pharmacovigilance (Spontaneous, clinical trial, literature and medico- legal cases), medical writing, MedDRA coding, Global regulatory submissions.

- Clinical trial designs, ICH-GCP, Ethics, Quality assurance and Quality control, Audits and Inspections, Clinical data management, Biostatistics. CORE COMPETENCIES

IT Tools

- Argus

- Sapphire

- Microsoft Office

- Content acquisition

ORGANIZATIONAL EXPERIENCE

Crest Pre-media Solutions (P) Ltd – Pune 2nd May 2014 – Present Designation: Scientific and Medical Writer

Role:

- Create summary content (case reports and E2B records) for adverse drug reactions from the published literature to support the drug safety reporting and information requirements of pharma industry clients.

- Thoroughly reviewing the published reports / biomedical literature to ascertain if they contain a case report of an adverse reaction.

- Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature.

- Write various safety reports (or part of such reports) for global regulatory submissions from literature articles.

- Write narratives for the adverse drug reactions and adverse events. Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures

Expertise:

- Pharmacovigilance (Literature cases), medical writing, MedDRA coding, global regulatory submissions.

- Determining seriousness of adverse events, causality assessment of all adverse event, subsuming signs and symptoms into clinical diagnoses

- Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities.

Tata consultancy services 02-Feb-2009 – 30-Apr-2014 Designation: Business process Lead

Role:

- Monitoring quality and making reports, assessing the quality performance of each individual with adherence to reporting timelines.

- Perform any other support activities as assigned - tracking various types of information and metrics, on-going QC of defined process steps, training, reconciliation of data from multiple sources including literature search.

- Experience on case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation and submission to regulatory authorities. Expertise:

- Pharmacovigilence (Medico-Legal, spontaneous and clinical trial cases)

- Understanding of global regulatory requirements

- On-going quality check of ICSR’s before regulatory submissions.

- Conducting update trainings to maintain quality as per client requirements.

- Effective communication skills both verbal and written Samrat Endocrine Institute Jul 2008 – Jan 2009

Designation: Clinical research coordinator

Role:

- Assisting investigator who will be responsible for the conduct of the trial at the trial site

- Assist recruiting and screening trial subjects for study

- Assist gathering data from consenting research subjects which includes obtaining informed consent, collecting, maintaining and organizing study information.

- Educating participants regarding study requirements

- Maintaining source documents and subject files in accordance with hospital procedures

- Coordinating with the ethics committee, to safeguard the rights, safety and wellbeing of all trial subjects

- Understanding of global regulatory requirements

- Travel to investigator meetings

Expertise:

- Clinical skills including vitals, blood pressure, collecting blood samples, managing emergencies

- Adherence to Good Clinical Practices

AMAI's Institute Of Urology And Research Centre Nov 2007 - June 2008 Designation: Clinical Research Coordinator and Research Assistant Role:

- Promote safety and confidentiality of research participants at all times

- Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives

- Plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures

- Obtain participant informed consent.

- Schedule tests and procedures.

- Collection of clinical research data.

- Ensure accuracy of documentation.

- Manage the use of investigational products and/or protocol specific products.

- Maintain databases.

- Document all correspondence and communication pertinent to the research.

- Interact and communicate effectively with research participants and the Sponsor and/or Sponsor’s representative

Expertise:

- Working as a Clinical Research Coordinator on an Exploratory, double- blind, randomized, parallel group, multi-centric study to evaluate the safety, tolerability and efficacy of Prosvent compared to placebo to provide symptomatic improvement in patients with Benign Prostatic Hyperplasia

- Verbal and written communication skills, proficiency in English language.

- Computer systems and software (Outlook, Word, Excel, PowerPoint, etc.)

- Good Clinical Practice and other clinical research regulations Vedic Life Sciences Pvt. Ltd January 2008- June 2008 Designation: Clinical research coordinator

Expertise:

- Working as a Clinical Research Coordinator on an Exploratory, double- blind, randomized, parallel group, multi-centric study to evaluate the safety, tolerability and efficacy of Prosvent compared to placebo to provide symptomatic improvement in patients with Benign Prostatic Hyperplasia

COMPANY PERIOD DESIGNATION

Crest Pre-media Solutions (P) Ltd 02-May-2014 –

Current

Scientific and Medical Writer

Tata consultancy services Feb 09- Apr 14 Business process Lead Samrat Endocrine Institute Jul 08 – Jan 09 Clinical research coordinator AMAI's Institute Of Urology And Research

Centre

Nov 07 – Jun 08 Clinical Research Coordinator and

Research Assistant

Vedic Life Sciences Pvt. Ltd Jan 08 – Jun 08 Clinical research coordinator Government Homoeopathic Hospital Feb 07 – Aug 07 House physician ACADEMIA

- P.G. Diploma in Clinical Research Birmingham College U.K 2008

- B.H.M.S. Maharashtra University of Health Sciences 2005

- H.S.C Rajarshi Shahu College 2001

- S.S.C Sharada Mandir High School 1999

COURSE WORK

Clinical trial designs, ICH-GCP, Ethics, Protocol writing and designing, Case report form designing, Quality assurance and Quality control, Audits and Inspections, Clinical data management, Biostatistics.

ACTIVITIES

Municipal Corporation - Aurangabad (February - 2003) Participant in Pulse Polio Programme as a Physician Municipal Corporation - Aurangabad (January - 2004) Participant in School Health Programme as a Physician Successfully participated in 13th, 14th and 15th National Homoeopathic Conference Successfully completed Naturopathy Certificate Course in May 2002 PERSONAL DETAILS

Date of Birth : 23rd July 1984

Location Preference : Flexible

Marital status : Married

Nationality : Indian

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