DEEPAK SAINI
Drug Safety Associate
Delhi
Summary
I have spent 3.9 years in the Pharmacovigilance industry. I have experienced in ICSR case processing, PSSR, Literature Safety, Triage, and Aggregate Reporting. I want to join the organization that provides pharmacovigilance services to customers, and I really liked it. So, I can learn more from the company, that will increase my knowledge, career growth and fulfill organizational goals.
Overview
4
4
years of professional experience
Work History
Pharmacist (content writer)
myUpchar.com (Doctorvahini Pvt. Ltd.)
07.2018 - 01.2019
- Website search related health topics
- Write medical content for myUpchar.com.
- Medical writing for Allopathic, Ayurvedic & Homeopathic medicine.
- Drug profiling and arrange adverse effects as per their severity grade.
- Writing description of medicinal salts and products (about 2000 till now).
Pharma Co-vigilance officer
Wipro Pvt. Ltd
06.2019 - 11.2021
- Being part of Pharmacovigilance team under Wipro Pvt Ltd.
- Performing single case creation in the Argus database.
- Data entry of reports in database.
- Proper narrative writing.
- Performing follow-up activities with HCP, Non-HCP and other company.
Drug Safety Associate || (PSSR)
Bioclinica India Pvt. Ltd
11.2021 - 08.2022
- Being part of PSSR Team under Bioclinica India Private Limited.
- Primary review was done for the Initial and Follow-up case processed by DSU.
- Performing case correction in the Argus tab and consolidate the Narrative as per source document provided.
- Familiar with adverse events,suspect products, types of reports, reporters and patients and Valid/Invalid criteria of reports.
- Good knowledge of MedDRA and WHO Drug Dictionary.
Senior Associate (Clinical Safety and Pharmacovigilance)
Soterius Life Sciences India Private Limited
06.2019 - 11.2021
- Literature search from PubMed and perform data entry of valid cases into safety database.
- Triage of safety information extracted from literature full text as well as from abstract.
- Assessment and quality review of literature safety information as per regulatory standards and client updates.
- Processing and evaluation of drug's safety, efficacy, and efficiency of Periodic Safety Update Report (PSUR), and Periodic Benefit Risk Evaluation Report (PBRER).
- Benefit-risk evaluation and compliance with regulations of Development Safety Update Report (DSUR).
Education
M.Pharm. (Pharmacology) -
Ch. Bansilal University
B.Pharm. - undefined
Pt. B.D. Sharma University of Health & Science
12th class - undefined
S.G.T.B. Khalsa Boys Senior Secondary School
10th class - undefined
Sarvodaya Kanya Vidhyalaya, Bharata Nagar
Skills
- Persistence and Optimistic
- Ready to take challenging work
- Ability to learn new technologies
- Capable of working with equal pace and accuracy under mental stress and pressure
- Proficiency in MS Office (Microsoft Excel, Word, PowerPoint etc) along with effective use of internet
- Drug Safety
- Adverse Event Reporting
- Medical Writing
- Medical Terminology
- Medical Coding
- MedDRA
- Handling of Argus, and Drug Safety Triage
Personal Information
- Father's Name: Sh. Surender Saini
- Date of Birth: 06/02/94
- Marital Status: Unmarried
Internship
National Institute of Malaria Research (NIMR), Dwarka Sector-8, New Delhi, 11/01/17, 04/30/18
Languages
English
Hindi
Projects
Artemisinin resistance in Plasmodium falciparum., Dr. Anoop Ankivar (Scientist F, Epidemiology and Clinical Research Division) NIMR-National Institute of Malaria Research Dwarka Sector-8, New Delhi-110077,India, Dr. Aakash Deep (Assistant Professor, Department of Pharmaceutical Sciences) Ch. Bansilal University, Bhiwani, Haryana.
Timeline
Drug Safety Associate || (PSSR)
Bioclinica India Pvt. Ltd
11.2021 - 08.2022
Pharma Co-vigilance officer
Wipro Pvt. Ltd
06.2019 - 11.2021
Senior Associate (Clinical Safety and Pharmacovigilance)
Soterius Life Sciences India Private Limited
06.2019 - 11.2021
Pharmacist (content writer)
myUpchar.com (Doctorvahini Pvt. Ltd.)
07.2018 - 01.2019
M.Pharm. (Pharmacology) -
Ch. Bansilal University
B.Pharm. - undefined
Pt. B.D. Sharma University of Health & Science
12th class - undefined
S.G.T.B. Khalsa Boys Senior Secondary School
10th class - undefined
Sarvodaya Kanya Vidhyalaya, Bharata Nagar
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