Sudarshan S
Senior Drug Safety Associate
Bangalore
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
6
6
years of professional experience
2
2
years of post-secondary education
4
4
Languages
Work History
Safety science specialist (CT)
Fortrea Development India Private Limited (formerly Labcorp)
05.2022 - Current
- Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.
- Be aware of all ongoing active and closed clinical trials of the sponsors.
- Work within Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
- Support upload/archival of case/study/project documentation, as appropriate.
- Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from clinical trial.
- Support compliance of operations with governing regulatory requirements
Senior drug safety associate
Accenture Solutions Pvt. Ltd
09.2021 - 03.2022
- Confirm accurate and consistent coding of medical history, drugs, and adverse event terms.
- Alert Medical Safety Physicians to potential safety issues and assist Medical Safety Physicians in monitoring safety profile of product as appropriate.
- Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
- To participate in audits or inspections
- Open to get trained and moved across roles based on business requirement.
- Confirm that Post Marketing Adverse Events are evaluated accurately and within required time frames to meet regulatory requirement.
Safety processing expert
Accenture Solutions Pvt Ltd
02.2019 - 09.2021
- Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events to confirm accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality
- Confirm accurate and consistent coding of medical history, drugs and adverse event terms
- Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting Medical Safety Expert whenever needed.
- Alert Medical Safety Physicians to potential safety issues and assist Medical Safety Physicians in monitoring safety profile of product as appropriate.
- Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs.
- To participate in audits or inspections
- Open to get trained and moved across roles based on business requirement.
- Successfully complete and clear Argus Core proficiency test
- Consistent demonstration of company values/behaviors.
Formulation optimizer and developer(R&D)
Chemlife innovation
03.2018 - 12.2018
- To do research on different type of formulation available
- Optimizing and developing formulation with better results
- Carrying out all required evaluation tests
- Solving issues with previously prepared formulations
- Documentation
- Consistent demonstration of company values/behaviors
- To participate in audits or inspections
- Resolving issues of different formulations within given timeline.
Education
M. Pharmacy (pharmaceutics) - Pharmaceutical Sciences
Karnataka College of Pharmacy
Bengaluru06.2018
B. Pharmacy - Pharmacy
Vivekananda College of Pharmacy
Bengaluru06.2016
PUC -
Sri Jagadguru Renukacharya PU College
Bengaluru 06.2010 - 04.2012
SSLC - undefined
Nivedhitha English school
Skills
Argus database
undefinedPublication
STATISTICAL DESIGN AND DEVELOPMENT OF A LIQUID ORAL FLOATING IN SITU GEL OF METFORMIN HYDROCHLORIDE FOR SUSTAINED RELEASE: PHARMACODYNAMIC AND TOXICITY (HISTOPATHOLOGY) STUDIES.
RASHMI MATHEWS1*, B. PRAKASH RAO2, ABBULU KONDE3, SUDARSHAN S.1, NAWRES A. TAHA4, SURESH C.1 (CY19).
ISSN-0975-7058
Disclaimer
I hereby declare that all the above information is true to the best of my knowledge.
Timeline
Safety science specialist (CT)
Fortrea Development India Private Limited (formerly Labcorp)
05.2022 - Current
Senior drug safety associate
Accenture Solutions Pvt. Ltd
09.2021 - 03.2022
Safety processing expert
Accenture Solutions Pvt Ltd
02.2019 - 09.2021
Formulation optimizer and developer(R&D)
Chemlife innovation
03.2018 - 12.2018
PUC -
Sri Jagadguru Renukacharya PU College
06.2010 - 04.2012
M. Pharmacy (pharmaceutics) - Pharmaceutical Sciences
Karnataka College of Pharmacy
B. Pharmacy - Pharmacy
Vivekananda College of Pharmacy
SSLC - undefined
Nivedhitha English school
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