JULIES SAGARE
Mumbai
Summary
Dynamic Safety Writer with extensive experience at FORTREA Scientific, excelling in Pharmacovigilance Aggregate data management and Signal detection. Proven track record in Aggregate data management, signal detection and quality control, enhancing pharmacovigilance systems. Adept at effective communication and problem-solving, driving operational efficiencies and ensuring compliance in drug safety evaluations.
Overview
11
11
years of professional experience
Work History
Safety Writer
FORTREA Scientific Private Limited
Mumbai
07.2021 - Current
- Reviewed and prepared comprehensive aggregate reports such as PADERs, PAERs, and annual reports.
- Drafting of PSUR's and PBRER's for applicable regulatory authorities. Generating line listing for PSUR and PBRER drafting
- Co-ordination with various stakeholders to gather data required for Aggregate reports
- Prepare and review RFIs (Requests for Safety Information) from health authorities.
- Compilation and management of aggregate safety data for regulatory reporting for PADER/PAER (Quarterly and Annual reports).
- Ensuring compliance and quality in aggregate reports activity.
- Contribute to drug safety activities to support product safety reviews and clinical evaluations, keeping abreast of changing PV requirements globally, with a specific focus on Rest of World territories. Contribute to the continued improvement of safety systems and processes.
- Contribute to the continued improvement of safety systems and processes. Actively coordinate with all the internal and external stakeholders, including members of the Medical Affairs, Regulatory Affairs, and Quality departments, towards the process.
- Actively coordinate with all the internal and external stakeholders, including members of the Medical Affairs, Regulatory Affairs, and Quality departments, towards the process.
- Submissions to the competent authorities on time for ensuring pharmacovigilance and regulatory compliance.
- Provide input into the Quality System as required.
- Support the team in pre- and post-action arising from PV audits and inspections.
- Seek and deliver operational efficiencies across the Drug Safety, Medical Affairs, and Regulatory Affairs teams.
- Seek and deliver operational efficiencies across the Drug Safety, Medical Affairs, and Regulatory Affairs teams.
- -Responsible for management for routine Safety surveillance. - Experience in signal detection activities including Signal identification, Evaluation and documentation of safety signals from the review of safety data. - Experienced in review and assessment of literature bulletins and published abstracts in accordance with searchstrategy. - Experience in handling tool for signal management. - MedDRA coding and SharePoint tool.
- Participated in the Train the Trainer program and trained newly hired associates on the signal detection process.
Safety Surveillance Scientist
Tata Consultancy Services
Thane
03.2019 - 07.2021
- To review the aggregate case reports from safety database using relevant designated management tool.
- To review and assess literature bulletins and published meeting abstracts in accordance with the with search strategy using relevant designated management tool.
- To conduct the initial evaluation of safety signals from routine review of cumulative safety data and document outcome according to specified criteria and requirements.
- To document potential signal and related information.
- To conduct further evaluation of safety signal as required by client.
- To prepare, summarize, evaluate and document routine Pre_SIRC safety outputs from dedicated safety database, dedicated external database (FDA, AERS, WHO Vigibase and Eudravigilance) and published literature.
Subject Matter Expert
Tata Consultancy Services
Hinjewadi, Pune
03.2016 - 03.2019
- Subject Matter Expert - (Individual Case Safety Report)
- Worked as a Subject matter expert (Drug Safety Specialist- Pharmacovigilance) in Tata Consultancy Services, Thane, Mumbai from MAR-2016 till date.
- Responsible for handling queries related to case processing, training of associates, scheduling of refresher training for updates related to case processing, conducting error analysis and incorporation of CAPA for late cases.
- Responsible for checking the quality of case triage, data entry, MedDRA coding of events and narrative writing.
- Confirm validity of a case, perform duplicate check, record date obtained and received.
- Assess seriousness, expectedness and causality and ensure accurate capture of each event term or reaction term at the event level as well as at the case level based on regulatory requirements and client's specific product rules.
- Responsible for prioritization of cases.
- Maintain necessary peer client communication related to case processing.
- Responsible for the creation, follow up and closure of the AE related queries with the client or relevant department as applicable.
- Ensure accurate and consistent coding of all events for serious and non-serious cases with the use of MedDRA (Medical Dictionary for Regulatory Activities).
- Performing Quality Control Check on all type of cases to ensure information reported to client is complete and accurate.
Junior Data Analyst- Case Processing
Cognizant Technology Solutions Pvt. Ltd.
Mumbai and Pune
08.2014 - 03.2016
- Data Entry and Quality Check of ICSRs in Pharmacovigilance database (ARGUS) and other case management activities
- Follow-up of serious and non-serious cases post marketing surveillance involving meticulous processing of patient reports received from the client's trial sites and marketed by abiding the standard operating procedures (SOP).
- Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.
- Involves important decision making for entering the case in to the data base, processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the provided labeling documents Company (Core Data Sheet, Summary of product information, investigator brochures etc.).
- Have been a part of the core team that is involved in the initial assessment of the cases before being entered in the database.
- Trained on literature surveys, reviewing, assessing and decision making for reportability by looking for positive attribution in the literature article.
- Conducting quality feedback meeting, huddles with Team members and discuss the frequent errors which identify in case processing.
- Triaging and book in of the valid cases.
- Performing spontaneous and clinical trial case processing.
Education
MBA - Pharmaceutical Industry Management
Padmashree Dr. D. Y. Patil University
Navi Mumbai01.2014
B. Pharmacy -
Bharati Vidyapeeth University
Pune01.2012
H.S.C. -
Shivaji University
Kolhapur01.2008
S.S.C. -
Shivaji University
Kolhapur01.2006
Skills
- Regulatory reporting
- Aggregate data management
- Signal detection
- MedDRA coding
- Literature review
- Drug safety evaluation
- Pharmacovigilance systems
- Quality control
- Regulatory compliance
- Safety data analysis
- Effective communication
- Problem solving
- Attention to detail
Languages
- English
- Hindi
- Marathi
Hobbies and Interests
- Travelling
- Surfing
- Listening Music
- Sports
Projects
Final project (MBA), A study on current scenario of market with reference to anti diabetic drugs. Bachelor of Pharmacy, Insomnia and its treatment. Class projects,
Project on consumer behaviour in pharmaceuticals 'Study on effect of emotions and communication of side effect on product prescription'., Designed product strategy for anti spasmodic product.
Development of a new product and its launch (Aloe-shave gel).,
Study on the view and awareness of OTC products among consumers.
Project on the perceptual behaviour in the organisation and its impact on the functioning of the organisation.
Locations
- Thane, Maharashtra
- Pune, Maharashtra
- Mumbai, Maharashtra
- Navi Mumbai, Maharashtra
- Sangli, Maharashtra
Personal Information
- Father's Name: Mr. Murlidhar B. Sagare
- Mother's Name: Mrs. Shakuntala M. Sagare
- Date of Birth: 09/29/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Safety Writer
FORTREA Scientific Private Limited
07.2021 - Current
Safety Surveillance Scientist
Tata Consultancy Services
03.2019 - 07.2021
Subject Matter Expert
Tata Consultancy Services
03.2016 - 03.2019
Junior Data Analyst- Case Processing
Cognizant Technology Solutions Pvt. Ltd.
08.2014 - 03.2016
MBA - Pharmaceutical Industry Management
Padmashree Dr. D. Y. Patil University
B. Pharmacy -
Bharati Vidyapeeth University
H.S.C. -
Shivaji University
S.S.C. -
Shivaji University
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