Team leader Clinical Research

CURRICULUM VITAE

DR. SHASHIKANT PATIL BAMS, M.Sc. in Clinical Research

Email id: - ***********@*****.***

Mobile: - +91-948*******/948*******

OBJECTIVES

As a versatile post-graduate who is physician by profession with firm sense of responsibility, self-motivation, commitment, creativity, hard work, self-discipline, and determination. Currently seeking a challenging career in pharmacovigilance where I can contribute my knowledge and skills set for growth and development of self and the organisation.

PROFESSIONAL EXPERIENCE: Total experience- 10 years in Pharmacovigilance)

ORGANIZATION

DOMAIN

Designation

DURATION

Cognizant

Technology

Solutions, Pune, Maharashtra

Pharmacovigilance

Team Leader

And Data Analyst (MedDRA SME)

As an SME from 13Apr2015 to 21Dec2020 and Working as acting

TL from 01Apr2022 and Ongoing (Current Job)

Quintiles

Technologies Pvt

Limited, Bangalore, Karnataka

Pharmacovigilance

Senior Drug Safety

Associate

23Jan2013 to 04Apr2015

Pooja Hospital,

Bangalore,

Karnataka

General Medicine

Resident Doctor

Apr2011 to Jan2013

FUNCTIONAL RESPONSIBILITIES

Cognizant Technology Solutions (13-Apr-2015 and ongoing)

Team leader responsibilities

• Allocation of cases for data entry, quality review and medical review on daily basis.

• Tracking of cases for completion based on regulatory, SLA and internal timelines. Prioritization of cases during a database lock.

• Responsible for providing mid-year and annual ratings and conducting appraisal for my tagged associates as per bell curve

• Currently I have a team of 18 associates reporting to me.

• Initiation of PIP programs for underperforming associates.

• Tracking of client mail boxes for queries and allocating it to designated associates on the floor as well as ensuring their completion within timelines.

• Tracking of cases for their completion as per SLA and regulatory timelines as well as completion of cases as per adhoc request from client.

• Responsible for providing feedback to associates and conducting performance meetings.

• Responsible for tracking training completion of associates who are tagged under me as per timelines.

• Managing the team activities to meet the compliance and deliverable targets.

• Participation in audit/inspection as required.

• Other case processing related activities (e.g. review of consistency checks, reconciliation, MLM literature search, and maintenance of case activity trackers).

SME activities

• Working as a subject matter expert and quality reviewer of solicited interventional clinical trial cases pertaining to diabetes and oncology studies.

• Having knowledge of processing as well as reviewing (QC) of Phase I-Phase IV clinical trial cases in Argus 8.0 database.

• Imparting training to the team on process updates from client as well as on protocol related matters.

• Communicating to the site investigator as well as medical reviewers regarding possible.

• SUSAR cases, for expeditedness as well as signal detection.

• Knowledge of drafting AOSE (analysis of similar events summary) in SUSAR clinical trial cases.

• Querying the site for further follow-ups and performing due diligence of clinical trial cases.

• Responsible for updation of protocol related company share points and also responsible for sharing key updates pertaining to changes in IB or study configuration.

• Having understanding of various regulatory submissions including E2B R3.

• Having knowledge of various regulatory reporting timelines for different types of cases throughout the globe.

• Responsible for database reconciliation for discrepancies, correction of errors found during reconciliation.

• Responsible for the development and ongoing maintenance of Pharmacovigilance Agreements (PVAs) and will ensure the most recent versions of agreements are stored within the PV Database

• Drafting the agreement based upon approved PVA templates

• Co-ordinating input into agreements from concerned parties

• Determining Companiess position and negotiating terms of agreement with third parties, co-ordinating review cycles and sign-offs and implementing agreements

• Maintaining and updating existing agreements as necessary

• Ensuring accuracy and up-to-date information of agreements in the Pharmacovigilance Tracking Database

• Maintaining status update of all agreements and ongoing work in PV Database

As a MedDRA coder/Quality reviewer/ Case processor in Cognizant (main responsibility):

• Search the safety database for duplicate reports. Evaluate case information for Medical Completeness.

• Each reported adverse event within a case is evaluated for potential upgrade for seriousness. Medical judgment is advised in deciding whether an upgrade is appropriate and the upgrade is documented.

• Code the following fields using the most appropriate

Lower Level Term (LLT) from MedDRA: o Medical history

o Reported adverse events,

o Other reported safety information,

E.g. medication error, pregnancy etc.

o indication for use of suspect and concomitant medications o labs and procedures

o cause(s) of death

o AssessExpectedness

o Create and update case narrative.

Quintiles Technologies Private Limited (23-Jan-2013 to 04-Apr-2015)

• Worked in chemotherapeutic product segment such as anti-cancer segment, consumer product segment, neuropsychiatric and immunological segment.

• Worked on SCEPTER safety database for expedited reporting of interventional clinical trial cases, serious/non-serious solicited cases, literature cases and spontaneous cases.

• Writing safety narratives for clinical trials for aggregate reporting purposes.

• Well versed in processing clinical trial, solicited, spontaneous and literature cases.

• To conduct triage of incoming reports for completeness, legibility and validity.

• To perform quality check (QC) for cases.

• Initial data entry of case reports into safety database / tracking system.

• Assessment of case reports for seriousness, causality and expectedness.

• Requesting follow-up i.e. written, telephone, e-mail, due diligence set up.

• Adverse event (AE) and drug coding using MedDRA and WHO dictionaries.

• Writing case narratives for solicited, spontaneous and clinical trial cases, AOSE narrative writing for pure clinical trial cases.

• Create and maintain project specific working files, case report files and project central files.

• Worked with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as: collection and review of endpoint packages o review and follow-up laboratory alerts, review and follow-up patient eligibility for inclusion / exclusion in clinical trials, review and follow-up protocol violations, review study specific case reports according to ICH/GCP criteria.

• Responsible for the development and ongoing maintenance of Pharmacovigilance Agreements (PVAs) and will ensure the most recent versions of agreements are stored within the PV Database

EDUCATIONAL QUALIFICATIONS

Degree

College & University

Passing Year

M.Sc Clinical Research

(India)Clinical Research Institute

2014

PGDCRM

(India)Clinical Research Institute

2011

BAMS

BLDE's Ayurveda Mahavidyalaya,

Bijapur

Rajiv Gandhi University of health sciences

2009

PUC

Department of pre University Bangalore

2004

SSLC

Karnataka Secondary Examination Board

2001

ACHIEVEMENTS

• At Cognizant Technology Solutions, Pune was awarded "SPOTLIGHT AWARD" for the month of JUL 2016, JAN 2017 and NOV 2017 for exemplary focus on performance excellence.

• At Cognizant Technology Solutions, Pune was awarded "UNICORN AWARD" for the month of MAR 2018 for spearheading high performance and quality.

• At Cognizant Technology Solutions, Pune was awarded "GAME CHANGER AWARD" for the month of MAR 2017 for shifting in performance standards. Paradigms of excellence.

MEMBERSHIPS

• Alumni Member of B.L.D.E, Ayurveda Mahavidyalaya College, Bijapur, Karnataka.

• Life member VIGI INDIA an NGO serving on non-profit basis, in the field of Pharmacovigilance (PV) and its allied field by promoting the awareness about the need for PV in India. Organizing the PV awareness programs, seminars on PV in Health sciences institutions to build the ADR reporting culture in India (www.vigiindia.org).

PERSONAL DETAILS

Father's name: Naganath Patil

Permanent Address: Plot No.45, GDA Colony, Gokul Nagar,

Near Shahabazaar. GULBARGA - 585101

Date of birth: 24-02-1986

Marital Status: Married

Nationality: Indian

Sex: Male

Languages known: English, Kannada, Hindi, Marathi.

Strengths: Fast self-learning abilities & self-confidence.

Current Address: 304, Balaji Vishwa, MHADA Wing, behind

Bharat petrol pump, Moshi, Pune-412105

DECLARATION

I hereby declare that the above information provided is true to the best of my knowledge.

Yours faithfully

Date: 04/11/2022

Place: Pune, Maharashtra

(Dr. Shashikant Patil)

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