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vidya biju%0264ab29151

Thiruvananthapuram, Kerala, India

C O N T A C T P R O F I L E

S K I L L S

E D U C A T I O N

WORK E X P E R I E N C E

Pharmacovigilance

Clinical Research

Clinical Data Management

Medication Errors Detection,

Reporting and Monitoring

Pharm D (Doctor of Pharmacy)

Osmania University / MNR College

of Pharmacy

Senior Pharmacovigilance Associate

TATA Consultancy Services - Mumbai, MH, India

Working in a Multiple drug product-based project, currently handling the role of a Medical Reviewer.

Has core knowledge in MedDRA coding, deals with various adverse event coding on daily basis.

Provides clinical knowledge when document amendments and updates to findings are required.

Guiding the implementation of strategies designed to achieve planned goals.

Handles E2B cases of spontaneous, solicited, literature, regulatory authority and post marketing case study in Argus Safety Database. Continuously working to understand the needs of customer and assisting to identify solutions that meet those needs.

Provided training to the onboarded associates along with regular refresher training for the associates and updated training documents to meet regulations and standards.

Supported inspections, client visits and audits as well as CAPAs management. Drafted technical documents such as deviation reports, testing protocol and trend analyses.

Received client appreciations during the training period. Worked in a Vaccine-based project.

Experienced in Argus Safety Database as well as the automated database of Converge Health Safety Database.

Worked as a Team Lead cum Trainer; managing a team of 30+ associates and monitoring the project to ensure progress.

Also handled the roles of a Quality reviewer and a Pharmacovigilance Subject Matter Expert (SME) efficiently.

Oversaw adverse events case reporting and conducted follow-up. Monitored deliverables for quality and adherence to regulatory reporting timelines.

Handled Clinical databases such as Electronic Data Capture (EDC) and iMedidata to review and maintain data management documentation, record management systems and identify tracking tools.

Reviewed production processes and identified potential quality issues. Collected and analyzed data to measure effectiveness of quality control processes. Conducted data review and followed standard practices to find solutions.

Received Star of the Month Awards (Jan & Feb 2022), Star Team Award 2021 and Client Appreciation Awards (2023).

April 2021 - Present

An ambitious healthcare professional with solid experience in Pharmacovigilance, Clinical Research and Clinical Data Management processes with hands free on Clinical data collection, Argus Safety Database, MedDRA Coding, ICSR processing, E2B book-in, Literature case handling, accurate data capture of Spontaneous/Regulatory Authority ICSR, clinical assessments including case seriousness, CAPA Management and implementation of Standard Operating Procedures and Corrective Action Plans. Bringing forth the ability of problem-solving, quick decision making, ability to work well with others and utilize my knowledge and leadership qualities to enhance the projects dealing with patient care. T O O L S

Argus Safety Database (Version 8.4.1)

Converge Health Safety Database

MedDRA (26.1)

D R . V I D Y A B I J U

S E N I O R P H A R M A C O V I G I L A N C E A S S O C I A T E Drug Information Services

Team Management / Leadership

Training & Mentorship

2014 - 2020

Graduation with Distinction

(Percentage: 84.58% - Gold Medalist)

iMedidata

Electronic Data Capture (EDC)

Microsoft Office (MS Powerpoint, MS Excel,

MS Word)

D I S S E R T A T I O N WORK

P U B L I C A T I O N S

"A Prospective Study on Reproductive Health

Problems and Menstrual Hygiene Practices

Among Women in Rural Population"

Research article published in International

Journal of Reproduction, Contraception,

Obstetrics and Gynecology, May 2022.

"Impact of Menstrual Health Education: A

Community Based Interventional Analytical

Study Among Rural Women of Eastern

Telangana"

Research article published in International

Journal of Pharmaceutical Sciences Review

and Research, October 2020.

"Identifying Medication Errors in a Tertiary

Care Teaching Hospital: A Prospective

Observational Study"

Research article published in Journal of Drug

Delivery & Therapeutics, November-December

2019.

Clinical Research Assistant

Medicover Hospital - Hyderabad, TS, India

Worked on a prospective interventional study performed on cardiac patients who underwent angioplasty.

Worked on a retrospective study performed on SARS CoV 2 virus infected patients with co-morbidities and those treated with antibiotics. Responsible for the data management of specific clinical studies. Assist in the review and approval of study case report forms (CRFs) and related databases for the safe storage of information. Ensure the accuracy and integrity of data collected from clinical research.

Prepare reports and organize presentations or meetings about clinical research progress.

Provide clinical knowledge when document amendments and updates to findings are required.

Review and maintain data management documentation, record management systems and identify tracking tools.

Worked in the hospital pharmacology department and provided patient care according to clinical protocols and safety requirements. Performed thorough research and analysis on data and created reports on research activities.

Effectively practiced as a clinical and dedicated team member. Reported the adverse drug reactions and drug interactions and ensured to improve patient's quality of life.

Took part in the NABH (National Accreditation Board for Hospitals & Healthcare Providers) audit.

Focused on therapeutic drug monitoring and evidence based patient care.

July 2020 - April 2021

L A N G U A G E S

English

Hindi

Malayalam

Clinical Pharmacist Intern

MNR Hospital - Sangareddy, TS, India

Worked as a passionate and dedicated Intern in the General Medicine, Surgery, Obstetrics & Gynecology and Pediatrics departments of the multi- specialty hospital.

Worked on a project titled 'A prospective study on reproductive health problems and menstrual hygiene practices among women in rural population' in the department of Obstetrics & Gynecology. Reported the drug interactions and adverse drug reactions identified in ward rounds and patient interactions.

Conducted patient counseling, provided in-depth clinical assessments as well as detailed drug information.

Actively participated in case presentations and published articles in international journals.

Counseled patients on new medications and OTC products. Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.

Communicated with patients to collect information about prescriptions and medical conditions.

Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.

August 2019 - July 2020

"A Prospective Study on Reproductive Health

Problems and Menstrual Hygiene Practices

Among Women in Rural Population"

A project conducted to identify the prevalence

of reproductive health disorders/problems

among rural women and to create awareness

among them to reduce its incidence.

C E R T I F I C A T I O N S

Registered Pharmacist, Kerala State Pharmacy Council, issued on 11th February 2021.

Infection Prevention and Control, issued by World Health Organization (WHO) on May 2020.

Good Clinical Practice, Version 5, issued by NIDA Clinical Trials Network on August 2020.

Telugu

Tamil

Contact this candidate