Ram Dilip Kumar Reddy Yatham
Hyderabad
Summary
Complaint Investigation Specialist & Licensed Pharmacist with nearly 5 years of experience in the medical device and pharmacovigilance sectors. Expertise in complaint handling, regulatory compliance (21 CFR 820, ISO 13485/14971), root cause analysis, and safety case processing. Proficient in tools such as Track Wise, Salesforce, SAP. Known for accuracy in documentation, cross-functional collaboration.
Overview
5
5
years of professional experience
Work History
Senior Safety Associate
4C Pharma Solutions
01.2023 - Current
- Conducted in-depth investigations of medical device complaints in compliance with regulatory and quality standards, including FDA 21 CFR 820 and ISO 13485.
- Coordinated with Field Service Engineers (FSEs) and customers to obtain necessary follow-up information for accurate complaint assessment.
- Assigned IMDRF codes and evaluated complaint reportability in accordance with applicable regulatory guidelines.
- Performed detailed root cause analysis (RCA) and collaborated with cross-functional teams to support issue resolution and CAPA recommendations.
- Summarized investigation outcomes and consistently worked to improve documentation clarity and quality.
- Contributed to trend analysis of complaints to identify recurring issues and supported CAPA initiation based on trend insights.
- Ensured audit-ready, high-quality documentation of complaint investigations in TrackWise, maintaining strong compliance with regulatory expectations.
- Recognized with the 'Best Team Player' award (Q3 2025) for outstanding collaboration, impactful contributions to complaint investigations, and effective cross-functional teamwork.
Drug Safety Associate
Qinesca Solutions India Pvt. Ltd.
06.2021 - 11.2022
- Processed adverse event (AE) and serious adverse event (SAE) reports.
- Conducted seriousness and listedness assessments.
- Maintained data quality and ensured adherence to regulatory timelines.
- Monitored adverse event reports for compliance with regulatory guidelines and protocols.
- Conducted quality checks on data entry to ensure accuracy and completeness of reports.
- Reviewed and analyzed safety data for potential risks and trends in drug safety.
Drug Safety Associate Trainee
Aquinova IT Solutions
05.2020 - 05.2021
- Performed case initiation, duplicate checks, and medical coding.
- Evaluated seriousness and processed both serious and non-serious cases.
Education
Bachelor of Pharmacy - B.Pharm
Chaitanya College of Pharmacy
01.2016
BiPC -
Sri Chaitanya Balaji Junior Kalasala
Guntur, AP01.2012
Secondary School Certificate - SSC
Sri Balachandra High School
Medapi, AP01.2010
Skills
- Medical device complaint handling
- Root cause analysis
- CAPA (Corrective and Preventive Actions)
- Complaint Trending
- Regulatory compliance (FDA 21 CFR 820, ISO 13485)
- Reportability Assessment (MDR, Vigilance, etc)
- IMDRF Coding
- Trend analysis
Hobbies and Interests
Playing cricket, Traveling, Listening to music
Timeline
Senior Safety Associate
4C Pharma Solutions
01.2023 - Current
Drug Safety Associate
Qinesca Solutions India Pvt. Ltd.
06.2021 - 11.2022
Drug Safety Associate Trainee
Aquinova IT Solutions
05.2020 - 05.2021
Bachelor of Pharmacy - B.Pharm
Chaitanya College of Pharmacy
BiPC -
Sri Chaitanya Balaji Junior Kalasala
Secondary School Certificate - SSC
Sri Balachandra High School
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