Open To Work
BHAVANI DANDEBOYENA
Bengaluru
Work Preference
Summary
Clinical research professional with experience in regulatory documentation and post-market surveillance. Achieved 100% on-time submissions while enhancing clinical evidence quality and compliance. Proficient in data analysis and cross-functional collaboration, ensuring robust safety assessments and effective project management. Experienced Senior Associate with analytical and flexible approach to solving problems. Decisive leader driven to optimize processes and streamline operations for team efficiency.
Overview
8
8
years of professional experience
Work History
Senior Associate II, Clinical Research
Alcon Laboratories India Pvt. Ltd.
Bengaluru
01.2023 - Current
- Prepared and maintained high-quality clinical evaluation and regulatory documents, including CERS, CEPS, PMCF Plans/Reports, CLRP, and S&P LSR, ensuring compliance with EU MDR (2017/745), MEDDEV 2.7/1 Rev. 4, MDCG, and IMDRF guidelines.
- Managed end-to-end Clinical Evaluation Report (CER) development for ophthalmic devices, integrating clinical, post-market, and risk management data into compliant, submission-ready reports.
- Conducted systematic literature searches and critical appraisal of scientific data to generate robust clinical evidence supporting device safety and performance.
- Collaborated with cross-functional teams including Regulatory Affairs, R&D, Clinical, and Quality to support new product development and lifecycle management projects.
- Coordinated multiple CER projects, ensuring timely adherence to milestones and effective document control processes.
- Ensured documentation quality and consistency through adherence to Good Documentation Practices (GDP) and AMA medical writing standards.
- Achieved 100% on-time submissions across three parallel device portfolios by optimizing milestone tracking and improving cross-functional coordination.
- Delivered audit-ready, submission-grade documentation with zero quality findings by ensuring strict adherence to EU MDR, MEDDEV, and Good Documentation Practices (GDP).
- Supported systematic literature reviews by conducting literature searches, critically appraising studies, and synthesizing data into structured clinical reports.
Senior Drug Safety Analyst
Accenture Solutions Pvt.Ltd.
Bengaluru
05.2019 - 01.2023
- Managed end-to-end processing of individual case safety reports, covering data entry and narrative writing.
- Reviewed adverse event case details to ensure appropriate actions based on SOPs and regulations.
- Oversaw comprehensive case intake from various sources, maintaining accuracy of mandatory fields.
- Ensured compliance with SLAs for timely case processing, boosting overall operational efficiency.
- Conducted follow-ups and reconciliations while resolving queries with sites and stakeholders.
- Executed lifecycle management activities for cases in line with pharmacovigilance processes.
- Performed systematic reviews of literature to enhance safety data reporting quality.
- Produced audit-ready documentation with no quality issues, ensuring adherence to regulatory standards.
Medical Writer
Parent lane
Bangalore
05.2018 - 12.2018
- Supported daily operations during internship, facilitating workflow and contributing to team objectives.
Education
Doctor of Pharmacy - Chittoor, A.P
Sri Venkateshwara College of Pharmacy
Chittoor, A.P01-2019
Intermediate - Vijayawada, AP
Sri Chaitanya Girls Junior College
Vijayawada, AP01-2013
Secondary Education - Sundipenta, AP
D.A.V Public School
Sundipenta, AP01-2010
Skills
- Post-market and clinical expertise
- Regulatory documentation writing
- PMS activities and reporting
- Support for clinical investigations
- PMCF strategy development
- Safety data assessment
- Analysis of real-world evidence (RWE)
- Review of clinical literature
- Appraisal of clinical data sets
- Management of literature and data sets
- Interpretation and analysis of data
- Analysis of risk versus benefit in studies
Awards
Star performance award, 2025
Timeline
Senior Associate II, Clinical Research
Alcon Laboratories India Pvt. Ltd.
01.2023 - Current
Senior Drug Safety Analyst
Accenture Solutions Pvt.Ltd.
05.2019 - 01.2023
Medical Writer
Parent lane
05.2018 - 12.2018
Doctor of Pharmacy - Chittoor, A.P
Sri Venkateshwara College of Pharmacy
Intermediate - Vijayawada, AP
Sri Chaitanya Girls Junior College
Secondary Education - Sundipenta, AP
D.A.V Public School