Sudarshan S
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
1
1
Certification
Work History
PSPM Support Associate
Fortrea (Formerly LabCorp)
Bangalore
05.2022 - Current
- Provide support for the set- up, maintenance and close out of Global or Regional projects in clinical trial and /or in post marketing studies, where delegated by the Global Safety lead of PSS Management team
- Support the Global Safety lead in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision
- Support the Global Safety lead in preparation of study specific job aids, instructions, trainings and templates
- Designed and executed data analysis plans to support pharmacovigilance and regulatory inquiries.
- Support systems set up during study start up and ongoing maintenance
- Support the Global Safety lead with project specific functional management for
- Developed interactive dashboards to communicate key findings to technical and non-technical stakeholders assigned projects (access requests, training assignment etc.)
- Support Global Safety lead with reconciliation of safety databases, if appropriate
- Support Global Safety Lead in drafting/modifying and delivering safety presentations as required, to external and internal stakeholders
- Support the Global Safety lead in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided
- Support the Global Safety lead in the preparation of safety documentation for internal, client or regulatory audits
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client
- Demonstrate role-specific competencies on a consistent basis
- Demonstrate company values on a consistent basis
Patient Safety Services Associate II
Fortrea (Formerly LabCorp)
Bangalore
05.2022 - 09.2024
- Assist in or complete per the safety management plan (SMP) the processing of all adverse event reports from any source
- Assist in producing queries of safety data for clients as appropriate
- Provide input for monthly status reports
- Maintains a comprehensive understanding of standard operating procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
- Demonstrate company Values on a consistent basis
- Assist Data Management or clients on reconciliation of safety databases
- Assist with the set-up of, and the provision of data to, safety committees/drug safety monitoring board (DSMBs)
- Cleaned and transformed diverse healthcare datasets to prepare for accurate analysis.
Senior Drug Safety Associate
Accenture Solutions
Bangalore
09.2021 - 03.2022
- 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
- Open to get trained and moved across roles based on business requirement
- Alert the Medical Safety Physicians to potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of product as appropriate
- Collaborate closely with cross-functional teams, including clinical and safety stakeholders, to understand their needs and develop analytical solutions.
Drug Safety Associate
Accenture Solutions
Bangalore
02.2019 - 09.2021
- Successfully complete and clear Argus Core proficiency test.
- Triage ICSRs, 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
- To participate in audits or inspections
- 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
Education
Masters of Pharmacy - Pharmaceutics
Karnataka college of pharmacy (RGUHS)
Bangalore, Karnataka, IndiaBachelor of Pharmacy - Pharmacy
Vivekananda college of pharmacy (RGUHS)
Bangalore, Karnataka, IndiaSkills
- Project Support
- Documentation skills
- Causality Assessment
- Communication Skills
- GCP guidelines
- ICSR Case processing abilities
- Triage of ICSRs
- ICD-10 CM Codes
- Labelling Assessment
- MedDRA Coding
- WHO DD Coding
- Research & Development
Systems experience
5 years, 2 years, 2 years
Therapeuticexperience
- Neurology: Neurodegenerative Diseases- Multiple Sclerosis (MS) (Phase IV Interventional)
- Immunology: Autoimmune Disorders- Ankylosing Spondylitis (Immune) (Phase IV Interventional)
- Hematology: Other Hematologic Disorders- Paroxysmal Nocturnal Hemoglobinuria (PNH) (Phase IV Interventional)
- Endocrinology: Metabolic Disorders- Hypophosphatasia (Phase IV Interventional)
- Nephrology: Genetic Disorders (Neph)- Atypical Hemolytic Uremic Syndrome (Phase IV Interventional)
Other
Not Applicable
Accomplishments
- 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
Languages
Hindi
First Language
Telugu
Intermediate (B1)
B1
Kannada
Proficient (C2)
C2
English
Proficient (C2)
C2
Certification
- Registered Pharmacist
Timeline
PSPM Support Associate
Fortrea (Formerly LabCorp)
05.2022 - Current
Patient Safety Services Associate II
Fortrea (Formerly LabCorp)
05.2022 - 09.2024
Senior Drug Safety Associate
Accenture Solutions
09.2021 - 03.2022
Drug Safety Associate
Accenture Solutions
02.2019 - 09.2021
Masters of Pharmacy - Pharmaceutics
Karnataka college of pharmacy (RGUHS)
Bachelor of Pharmacy - Pharmacy
Vivekananda college of pharmacy (RGUHS)
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