Sangeeta Saraswat
Drug Safety Associate - Level 2
Uttar Pradesh
Summary
Drug Safety Associate - Level II with 4+ years of experience conducting research to study human diseases and drive healthcare improvements. Investigative professional leading clinical research to support diagnosis and treatment of diseases. Critical thinker with background developing and improving methodologies and procedures for superior data analysis and reporting.
Core Expertise
- Handling global compliance on Pharmacovigilance matters.
- Handling Pharmacovigilance training activities.
- Pre-Startup Safety Review (PSSR).
- Individual Case Safety Reports (ICSR).
- Update, Review and maintenance of global company product list and company product dictionary for Pharmacovigilance department.
- Processing and quality reviewing of Clinical trial cases, spontaneous, Literature, Legal, PMS, Registry cases, Retrospective pregnancy cases, E2B cases, Licensing Partner and Regulatory cases. Reconciliation of monthly data.
- Handling Standard operating procedure (SOPs) related activities.
- Handling Intake of cases in medical safety database.
- Having knowledge on ARGUS, SAPPHIRE, CARA, Meridian, Regulatory Submission Guidelines and current FDA regulations.
Overview
5
5
years of professional experience
7
7
years of post-secondary education
2
2
Languages
Work History
Drug Safety Associate - Level II
Bioclinica
Mysore
12.2021 - 08.2022
- Working as PSSR, Review and evaluate AE case information to determine required action
- Quality Review of post marketing/solicited, spontaneous and literature cases adhering to Standard Operating Procedure
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Process all incoming cases in order to meet timelines
- As a medical coder and safety narrative as required
- Responsible for coding all medical history, events, drugs/procedures/indications/ and laboratory test according to the appropriate dictionary (For eg
- MedDRA, Company Product Dictionary, WHO-DD)
- Code products specified as suspect or concomitant by the reporter
- Provide the narrative, as required
- Initiate follow-up activities to obtain additional information and clarification, as appropriate
- Confirms event term selection and coding and confirms/assesses event seriousness
- Identify spontaneous cases that are a result of stimulated reporting by adding the appropriate case classification
- Correct the data entry errors, if any, prior to routing the case in the global safety database
- Maintain knowledge and understanding SOPs and current FDA regulations.
- Navigated intricacies of drug safety databases to process adverse event reports.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
Patient Safety Administrator
Tata Consultancy Services
Mumbai
02.2019 - 12.2021
- Work as a Patient safety Administrator data entry of safety case reports
- Good speed in performing data entry with an auto narrative
- Accurate data entry and coding of AE reports and evaluation of expedite and non-expedited reports within well-defined timeframes, in compliance with Drug Safety and Epidemiology business rules, SOP and regulatory requirements
- Processing spontaneous and NIS case category A, B, C-SUSAR, C-SSAR, C- KUR, C-EU, ICSR, E2B cases
- Processing the Individual Case Safety Reports (ICSR) from different sources i.e
- Clinical, Non-interventional studies, Marketing Program, Spontaneous, Health Authority, Compassionate use cases and various Licensee Parties in the Pharmacovigilance database
- Responsible for identifying duplicate/invalid ICSRs in SAPPHIRE and handling as per relevant SOP
- Accountable for handling ICSRs or E2B files received via data exchange systems, disposition of valid items into SAPPHIRE
- Acknowledging receipt of ICSRs to the sender within the timelines documented in the relevant SOP
- Accountable for sending queries for clarity associated with incoming information if required
- Assuring compliance with the use of the Client Safety database through reference to the latest SOPs and relevant manuals
- Demonstrated knowledge of safety concepts, global regulatory reporting obligations, relevant PDSO SOPs, Pharmacovigilance Agreements and Safety Data Exchange Agreements
- Responsible for developing a collaboration with relevant Drug Safety Personnel for maintaining awareness of critical AEs, knowledge of labeling documents (CDS, Eu-SPC, USA, IB), and other issues for company products
- Professional Strengths Include
- Proficient in using the Global safety database of Sapphire (version: 3.4) and MedDRA drug coder and PSI
- Case processing, well versed with MedDRA
- Expert in Case processing and Data Entry of Non-interventional studies/programs, Spontaneous and all Special situation cases like A, B, C-SUSAR, C-SSAR, C- KUR, C-EU, ICSR, E2B
- Manage, Plan and Organize work assignments and work under strict timelines
- MS-Office, Meridian Software
- Manpower Supervision, Excellent communication skills, both written and verbal.
Data Analyst
Accenture
Bengaluru
06.2018 - 01.2019
- Software Contract with Accenture
- Worked with Mondelez to generate reports on Meridian Software for products to check the data and generated the report
- Assess the identity, strength, orpurity of beverages, chocolates etc
- Maintain records, such as Mondelez files, inventories.
Bharat Serums And Vaccines Limited
Bengaluru
09.2017 - 05.2018
- Worked as researcher in-vitro fertility drugs, to work with the study based on protocol,explain a consent form to the subject, maintain subjects' case reports form (CRF)
- Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability
- Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage.
Education
Master of Pharmacy - Quality Control And Safety Technologies
Pacific College of Pharmacy
Udaipur, India 07.2020 - 10.2022
Bachelor of Pharmacy - Pharmaceutical Sciences
PSIT - Pranveer Singh Institute of Technology
Kanpur, UP, India 07.2013 - 11.2017
PG Diploma - undefined
Institute of MSC Clinical Research
Skills
TECH SKILLSundefined
Timeline
Drug Safety Associate - Level II
Bioclinica
12.2021 - 08.2022
Master of Pharmacy - Quality Control And Safety Technologies
Pacific College of Pharmacy
07.2020 - 10.2022
Patient Safety Administrator
Tata Consultancy Services
02.2019 - 12.2021
Data Analyst
Accenture
06.2018 - 01.2019
Bharat Serums And Vaccines Limited
09.2017 - 05.2018
Bachelor of Pharmacy - Pharmaceutical Sciences
PSIT - Pranveer Singh Institute of Technology
07.2013 - 11.2017
PG Diploma - undefined
Institute of MSC Clinical Research
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