Subject Matter Expert - SME (Pharmacovigilance and Clinical)

CV – DR. FORUM S. SHAH

Email: ************@*****.*** Contact: +91-992*******

ACADEMIC QUALIFICATIONS

K.B.I.P.E.R, KADI SARVA VISHWAVIDYALAYA JAN 2014

Gandhinagar, Gujarat, INDIA

Ph.D., Pharmaceutical Sciences (Pharmacology)

INSTITUTE OF PHARMACY, NIRMA UNIVERSITY APR 2005 – MAY -2007

Ahmedabad, Gujarat, INDIA

Master of Pharmacology, Pharmacy

B.M.C.P.E.R., NORTH GUJARAT UNIVERSITY AUG 2001 – APR 2005

Modasa, Gujarat, INDIA

Bachelor of Pharmacy with Distinction

CURRENT WORK PROFILE

SARJEN SYSTEMS PRIVATE LIMITED DEC 2014 – PRESENT

Subject Matter Expert – SME (PV and Clinical)

OPERATIONAL ACTIVITIES AS AN SME

Planning Pharmacovigilance roadmap with respect to upcoming regulatory norms and requirements to be considered in priority

One of the key responsible personnel of Company for attending and responding to Client audits, third party audits and closing findings

Leading in implementation of veterinary PV database, medical inquiry database

Performed thorough analysis for major development CRs (change requests) like MedDRA auto update, Signal Detection enhancement, Case assignment, PADER listings etc.

Project Management for PV clients within targeted Project Management Plan (PMP) timelines

Drafting and supervising documentation related to Software Development life cycle (SDLC) – URS, FS, PMP, PQs, USA, UAT, RA etc.

Heading project management team to carry out all applicable validation documentation for project implementation, version releases, project re-validation and other client deliverables

Assisting PV team in interpretation and correct application of global regulations

Giving training on comprehensive PV software with value-addition to the already existing clients for enhancements in database and to new clients as a part of project implementation

Referral to various guidelines for up gradation of solution as per latest regulatory standards and electronic compliance mandates

SOCIAL MEDIA BRANDING AND MARKETING ACTIVTIES AS AN SME

Contributing to knowledge-sharing platform through delivery of interactive Web-based seminars (already delivered Webinars on the topics like Compliance to GVP guidance, literature automation, signal detection, medical inquiry, ISO IDMP standards, PADER reporting etc.).

Note: For more information, please visit www.sarjen.com (for downloading and viewing my Webinars as a Speaker)

Responsible for lead generation, lead nurturing activities and networking for branding

Writing blogs, White papers and case studies for promoting and building software image (please check out pvnet.sarjen.com website for the same)

Updating website pages periodically for newer features in solution

Pivotal contribution in promoting and branding Company's effective presence in market

Demonstrating software to potential prospects and responding to functional queries

Actively involved in Client communications to ensure service satisfaction, regulatory compliance and issues management

Forecasting and planning for major guidelines implementation (such as ICH E2B(R3) and ISO-IDMP standards)

Effective management and training of other databases such as PrITR (Product Inquiry trail and response/Medical inquiry, Ethics Committee management of SAEs

MY ENRICHING WORK EXPERIENCE

IMPERIAL INSTITUTE OF CLINICAL RESEARCH MAY 2014 – JULY 2014

Visiting Faculty

Delivering lectures related to guidelines and operations in clinical research

Undertaking workshops for document preparation

WORK EXPERIENCE

ETHICARE CLINICAL TRIAL SERVICES – CRO JULY 2012 – APRIL 2013

Business Development & Operations

Building and Networking for Business Development

Communication with Sponsor Companies for pipeline projects

Preparing and Delivering presentation on CROs core expertise and experience

Correspondence with MNCs for planning and arranging meetings

Compiling local and international database of Clients

Preparing and circulating Minutes of meeting

Approaching clients through various media, providing technical details of CRO, follow up including closing the deal

Preparing Protocol synopsis based on the Client’s requirements

Working knowledge of PSUR

MANAGEMENT - INDEPENDENT ETHICS COMMITTEE

Planning, Coordinating and Arranging Independent Ethics Committee activities

Preparing and maintaining Ethics Committee documentation pre- and post-meetings

Preparing Standard Operating Procedures pertaining to Ethics Committee functioning

Preparing and circulating Minutes of Meeting

Correspondences with the Client till the final approval of Protocol

Working knowledge of guidelines pertaining to IEC operations

Registration of IEC in OHRP, US-DHHS

Pro-actively communicating with IEC members for amendments, adverse events, additional documents etc.

Know-how of Protocol and presentation of a brief summary to the members

Served as a Coordinator to Ethics Committee for four years

APL INSTITUTE OF CLINICAL LABORATORY & RESEARCH PVT. LTD.

Diagnostic Experts since 1975… MAY 2011 – MAY 2012

Sr. Research Associate & Business Development Officer

Preparing Central Laboratory Documentation of SOPs, Manuals

Presentation and Management for Investigator’s Meet

Site Logistics & Supplies

Correspondence & Communication for site related queries and its resolution

Meeting potential Investigators for business development

Activities for Central Laboratory business promotion

Updating and Maintenance of Organization website

Inputs for the Laboratory Information Management System

Internal Team Management for Clinical trials

First point of contact for clinical studies

First point of contact for Sponsors and CROs

Compliance to documentation for different business activities as well as Lab accreditation

Supporting and facilitating personnel for laboratory accreditation requirements

Facilitating audit requirements for Central laboratory internal and external audits

Preparing laboratory documents for Sites recording of laboratory parameters and laboratory related adverse events

SHIVRATH COE IN CLINICAL RESEARCH APR 2009 – APR 2011

A Joint Venture with GSBTM, Govt. of Gujarat & affiliated to

Dept. of Microbiology, Gujarat University

Technical Expert

Training pertaining to the Modules of Clinical Research training program

Member Secretary to Jagruti Independent Ethics Committee, registered under USDHHS

Administration in absence of Director

Supervision of Assignment, Case studies & activities allotted to participants

Syllabus Designing

Arrangement of Company (CRO) visits, Conferences & Events hosted by the Institute

Handled Technical Department in the process of ISO 9001:2008 certification (accomplished in Feb 2010)

Sharing ideas on marketing gimmicks used as a tool to bring potential candidates

Involved in the academia development activities to build a robust image of the Institute

CORPORATE - STERLING HOSPITAL (INDIA) JULY 2007 – APR 2009

Clinical Pharmacist

Coordinated with Primary & Visiting Consultants for implementation of Drug Formulary

Monitoring ADRs & medication errors in drug administration, prescription, transcribing etc.

Worked in Research & Development wing for coordination of projects under Investigator

Coordination of Ethics Committee Meetings & formulation of Minutes of Meeting

Vital Participant of a Team involved in NABH Accreditation of Hospital

Worked in “Quality Assurance Department” for National Accreditation of Hospitals & Health care providers (NABH) for Sterling Hospital, Ahmedabad & Baroda (designated as Corporate Quality Team – INDRADHANUSH)

Development of the quality and safety systems, policies, processes and SOPs as per the Accreditation Standards (i.e. National Accreditation board for Hospital & Healthcare Providers - (NABH)

Conduction of training programme on Clinical Pharmacy, infection control practices

Development and implementation of Documentation control system

Constitution and coordination of various Committees in the Hospital as per the scope and monitoring the functioning of Pharmaco therapeutic Committee, Quality Assurance Committee, Infection Control Committee, Ethics Committee

Carried out Internal Assessment of all Clinical and Non clinical Departments

Development of Indicator Monitoring System for Hospital and monitored indicators like patient satisfaction, ADR rate, Medication Error rate, Hospital acquired infection rate, patient hospitalization

ON-CAMPUS TRAINING

B.V. PATEL PERD CENTER MAY – 2006

Trainee (1.5 months)

Referring Journals for planning of pre-clinical project

Development of Diabetic & Inflammatory models and their treatment

Learning Good Laboratory Practices

GRADUATE LEVEL COURSEWORK & ACADEMIC PROJECTS

To comply better with job requirements recently completed a certificate course “Module – 1 – Marketing tactics and Body language – level A1 from Connpeopleffectivity Organization.

Being a true self-learner, frequently attend Ahmedabad Management Association (AMA) sessions on motivation and technical topics

Attended training sessions on Healthcare Accreditation by Dr. Y.P. Bhatia, Director, Astron Healthcare, Delhi

Attended ICMR sponsored Seminar on “Biostatistics in Pharmaceutical Sciences” at K.B. Institute of Pharmaceutical Education & Research Center, Kadi Sarva Vishwavidyalaya

Attended the National Conference with the theme, “Shifting Paradigms In Head & Neck Oncology”, organized by Gujarat Society of Head & Neck Oncology (G-SHNO) on 17th February, 2007

Attended IPC (Indian Pharmaceutical Congress) held at Pune-2003, Chennai-2004, Ahmedabad- 2009

‘Pharmacokinetic Analysis Of One Compartment Model’ in Final B.Pharm

Vision 2010 Analytical techniques & Instrument for Industries, Research & Academics, 15th Oct.2005, Ahmedabad

Attended the International Workshop on Adverse Drug Reaction Monitoring (11th November, 2005) & Fifth Annual Conference of Society Of Pharmacovigilance (India, 12th-13th November, 2005).

‘Prevalence of Head and Neck Cancer and An Overview of Its Treatment Modalities’ (Medisurge Hospitals, Ahmedabad) conducted under guidance of Dr. Kaustubh Patel, Head & Neck Oncosurgeon

PUBLICATIONS

E-Publication of Paper submitted online on the topic entitled “Prevalence Of Head & Neck Cancers in Ahmedabad, Gujarat” in Indian Journal of Otolaryngology & Head & Neck Surgery

Link- http://dx.doi.org/10.1007/s12070-008-0104-z

Publication of Ph. D work: http://scholarsresearchlibrary.com/dpl-vol4- iss3/DPL-2012-4-3- 1013-1021.pdf

Research publication entitled “Single versus combined atorvastatin and lasuna: Investigating changes in laboratory parameters and Hydrogen sulfide post treatment” published in International Journal of Pharmtech Research

Research publication entitled “Comparison of lasuna with atorvastatin & its investigation of hydrogen sulfide release in obsess and/or hyperlipidemic cases published in Der Pharmacia Lettre

ACHIEVEMENTS & ALLIED ACTIVITES

Participated in the Pharmacy Awareness Program organized at BMCPER College.

Secured 1st Rank in Third year B. Pharm.

Hosted events like Cultural Festival at Pharmacy College and the State Level Nirma Quest

Stood second in the State Level Elocution competition held in LMCP, Ahmedabad

Initiated and coordinated Business Development with a Canadian company for a promising

drug candidate to outsource work in India

BRIEF ABOUT ME

I am a dedicated person and believe in making environment conducive to work for healthy, mutually beneficial relations. I believe that when you are passionate and focused about work, quality will surely be the by-product.

I can work effectively in a team as well as take leadership to raise the bar alone. With my experience in healthcare, academia, clinical research, pharmacovigilance and allied fields, I can surely be an asset to the Organization owing to my flexible personality, ability to communicate with conviction, adapt to changing and demanding work place environment and a craving to do better every day. I firmly believe in personal growth in terms of an individual, professional and as a team player. Given a task, I will make sure to understand it thoroughly and do it with innovation, a self-driven thought process and most importantly, try to do it differently and effectively to achieve a benchmark.

PERSONAL DETAILS

Date of Birth: 12th July 1984

Marital Status: Married

Contact: (M) +91-992*******, (R): +91-79-267*****

Residential Address: 11, Niharika Bunglaws, Opp. Himmatlal Park, Near

Azad Society, Ambawadi, Ahmedabad – 380 015, Gujarat, INDIA

REFERENCES

Mr. Kapil Jhawar,

Associated with Quintiles CRO, Ahmedabad

Mr. Atit Sheth

Recently joined Quintiles CRO, Ahmedabad

Dr. Lubna Mansuri,

Manager – CIMS Hospital, Ahmedabad

Dr. Kaustubh Patel – Head & Neck Oncosurgeon,

HCG – Medisurge Hospitals, Ahmedabad

Dr. Gaurang B. Shah – Ph.D. (Pharmacology), Principal & Researcher

K. B. Institute of Pharmaceutical Education & Research, Gandhinagar

Contact this candidate