Deepti Bogi
Bengaluru
Summary
Dynamic medical safety writer with extensive experience in medical safety reporting, excelling in regulatory compliance, and risk assessment. Proven track record in authoring critical safety reports and enhancing pharmacovigilance processes. Adept at cross-functional collaboration and data analysis, driving continuous improvement initiatives to ensure product safety and regulatory adherence.
Overview
12
12
years of professional experience
Work History
MEDICAL REVIEWER
ALCON
Bangalore
08.2023 - 09.2024
- Perform medical review of ICSRs and/or aggregate data involving the assigned product(s), facilitate risk assessment for Manufacturer Incident Report (MIR)
- Provide safety input to the PSUR and CER deliverables
- Monitor the clinical safety of assigned products/projects, including adverse events and patient impact from technical complaints from studies, literature, and post-market surveillance
- Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance
- Prepare literature summaries on special topics to characterize product safety profile and support risk management documents
- Support the preparation and maintenance of post-market surveillance plans (PMSP), periodic safety updates, product labelling and related documents
- Support the preparation of health hazard assessments and responses to inquiries from health care authorities, health care professionals, or local affiliates
- Support Safety data science team as safety subject matter expert on development of cognos reports and applications for data retrieval and assessment from sales and complaint databases
- Contribute clinical, scientific knowledge to support the cross functional team
- Contribute to the development of local brand plans & medical strategies
- By offering scientific and creative input, contribute to the development (local materials) and/or review (global/regional materials) of promotional and non-promotional materials
- Effectively communicate and transfer knowledge of the therapeutic available solutions environment, the clinical landscape and relevant medical and scientific information
- Support business development and licensing activities, health authority inspections/audits, and market action activities
SENIOR MEDICAL SAFETY WRITER
ALCON
Bangalore
08.2022 - 08.2023
- Author regulatory safety information required for Similar Device protocol and Similar Device report and PSUR, PMSR, China PRER, Mexico ITV, Egypt SMH, Canada PSUR and India PSUR
- Prepare EU and ROW PSUR submission roaster, internal stakeholder management for the Rest of the World PMS reports
- Provide Safety sections inputs for the Clinical Evaluation Report (CER) preparation and Perform review of safety sections of the Clinical Evaluation Report (CER)
- Gather, organize, and interpret the relevant safety data for assigned projects; collaborate with functional subject matter experts to ensure document accuracy, comprehensiveness, quality, and regulatory compliance
- Collaborate with Local Regulatory Point of Contacts for timely preparation and submission of the reports submitted outside Europe
- Provide safety data support for new device registrations and renewals as per the Local country requirements
- Support the preparation of Post Market Safety report templates as per the Local Health Authority regulations, support continuous improvement initiatives based on the latest EU MDR regulationsAuthored regulatory safety information for Similar Device protocol and Similar Device report, PSUR, PMSR, China PRER, Mexico ITV, Egypt SMH, Canada PSUR and India PSUR.
- Prepared EU and ROW PSUR submission roaster, managed internal stakeholders for Rest of the World PMS reports.
- Provided safety sections input for CER preparation and reviewed safety sections of CER.
- Gathered, organized, and interpreted relevant safety data for assigned projects.
- Collaborated with functional subject matter experts to ensure document accuracy, comprehensiveness, quality, and regulatory compliance.
- Collaborated with Local Regulatory Points of Contacts for timely preparation and submission of reports submitted outside Europe.
- Provided safety data support for new device registrations and renewals as per local country requirements.
- Supported the preparation of Post Market Safety report templates as per Local Health Authority regulations, and supported continuous improvement initiatives based on the latest EU MDR regulations.
MEDICAL WRITER II
PAREXEL
India
10.2021 - 08.2022
- Authoring of Periodic Safety Update Report (PSUR) for submission to the Regulatory Authorities
- Collaborate with Client and Cross sector counterpart for the preparation of PSUR
- End to end timeline management of multiple projects related to aggregate report submissions
- Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed
ASSOCIATE MANAGER
ELANCO
Bangalore
10.2019 - 10.2021
- Authoring of Periodic Safety Update Report (PSUR), Canada Annual Summary Report, Australia Annual Summary Report, Chile, and Saudi Arabia safety reports for veterinary pharma products
- End to end timeline management of multiple projects related to Aggregate report submissions
- Preparation of Sales Distribution Report to analyze the Incidence and Ratio of occurrence of adverse events with a product/drug
- Authoring of Ad hoc Safety update report for the Regulatory Authorities
- Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed
- Mentoring new joiners and essential trainings for new joiners
SENIOR ASSOCIATE MEDICAL WRITER
INDEGENE PVT LTD
Bangalore
03.2016 - 10.2019
- Preparation of Aggregate reports like Periodic Benefit Risk Evaluation Report (PBRER), Pregnancy Lactation Labelling Review (PLLR) and Addendum to Clinical overview (ACO), Canadian Annual Summary Report (CAR), Periodic Safety Update Report (PSUR), and Periodic Adverse Events Report (PADER) specific to the country of submission
- Performed quality check of PBRERs, ACOs and PADERs before submission to the authorities, Systematic Literature search
- Life cycle management of the Aggregate report submission and ensured maintenance of the reports in the Client server and portals
- Mentoring new joiners
DRUG SAFETY ASSOCIATE
QUINTILES
Bangalore
02.2015 - 02.2016
- Assessment of various Adverse Event reports involving the Client's products
- Triaging of the reports to the Pharmacovigilance database, creation of cases, MedDRA coding of the Adverse events reported on Argus Pharmacovigilance Database
- Case processing and individual case narrative writing as per the Guidelines to meet the FDA, EMEA, and Business Partner and Local Health Authorities Submission timelines
- Literature Report assessment for triaging in the database, literature adverse event coding, and case processing for submissions
- Spontaneous case creation from various adverse event reporting forms, Memos, Regulatory reports, and Literatures
- Efficient with MedDRA coding convention for Adverse event reporting to the Authorities
DENTIST
GOVERNMENT DENTAL COLLEGE
Raipur
01.2013 - 12.2013
- Experienced in managing Outpatient check-up and diagnosis of Dental ailments
- Worked as a Community Dentist serving the Local government schools and prison
- Participated in Dental healthcare programs conducted by the Government Hospital
- Specific Dental treatment skills include minor dental surgeries, prosthodontic, pedodontics, and endodontic treatments
Education
DIPLOMA - CLINICAL RESEARCH AND PHARMACOVIGILANCE
AVIGNA INSTITUTE OF CLINICAL RESEARCH
01.2014
BACHELOR'S DEGREE - DENTAL SURGERY
GOVERNMENT DENTAL COLLEGE
RAIPUR, CHHATTISGARH01.2012
Skills
- Medical writing
- Risk assessment
- Data analysis
- Regulatory compliance
- Safety reporting
- Project management
- Cross-functional collaboration
- Knowledge transfer
- Adverse event reporting
- Pharmacovigilance processes
- Continuous improvement
- Database management
- MS Office
- Veeva Vault
- Argus Database
- Track wise Database
- PV Works Database
Disclaimer
I hereby affirm that the particulars furnished above are true to the best of my knowledge., Bangalore, India, 01/27/25
Timeline
MEDICAL REVIEWER
ALCON
08.2023 - 09.2024
SENIOR MEDICAL SAFETY WRITER
ALCON
08.2022 - 08.2023
MEDICAL WRITER II
PAREXEL
10.2021 - 08.2022
ASSOCIATE MANAGER
ELANCO
10.2019 - 10.2021
SENIOR ASSOCIATE MEDICAL WRITER
INDEGENE PVT LTD
03.2016 - 10.2019
DRUG SAFETY ASSOCIATE
QUINTILES
02.2015 - 02.2016
DENTIST
GOVERNMENT DENTAL COLLEGE
01.2013 - 12.2013
DIPLOMA - CLINICAL RESEARCH AND PHARMACOVIGILANCE
AVIGNA INSTITUTE OF CLINICAL RESEARCH
BACHELOR'S DEGREE - DENTAL SURGERY
GOVERNMENT DENTAL COLLEGE
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