Dipak Reddy
Chinchwad, Pune
Summary
Results-driven Drug Safety Professional with extensive experience in pharmacovigilance operations and proven expertise in:
• Processing 1000+ Individual Case Safety Reports (ICSRs) with 99.5% accuracy rate
• Conducting thorough medical assessments and causality evaluations
• Expert knowledge of ICH guidelines, GVP modules, and regulatory requirements
• Advanced proficiency in safety databases (ArisG, Argus) and medical coding (MedDRA, WHO-DD)
• Strong track record in quality review and narrative writing
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Drug Safety Associate
Tata Consultancy Services (TCS)
Pune, Maharashtra
05.2024 - Current
- Process and manage pregnancy and medical device safety cases using Argus Safety Database with 99% accuracy
- Perform comprehensive data quality reviews to ensure compliance with ICH guidelines and regulatory requirements
- Monitor and analyze safety data trends to identify potential signals and areas for improvement
- Validate adverse event coding using MedDRA terminology and WHO Drug Dictionary
- Maintain strict adherence to global pharmacovigilance SOPs and timelines
- Collaborate with cross-functional teams to ensure data consistency and accuracy in safety reporting
- Generate detailed safety narratives for regulatory submissions
- Support E2B transmission and validation of safety reports to health authorities
Drug Safety Associate
Qinecsa solution (bioclinica)
Mysore
04.2021 - 05.2024
- Processed 1000+ Individual Case Safety Reports (ICSRs) with 99.5% accuracy rate in ArisG database
- Performed medical assessment and causality evaluation for adverse events
- Conducted literature screening and case triage for safety signal detection
- Authored comprehensive safety narratives following ICH E2B(R3) guidelines
- Managed end-to-end case processing from intake to regulatory submission
- Utilized MedDRA and WHO-DD for accurate medical coding of adverse events
- Contributed to the development of Standard Operating Procedures (SOPs)
- Participated in quality review meetings and process improvement initiatives
Education
Master of Science - Pharmacy
Channabasweshwar Pharmacy College
Latur, Maharashtra11.2020
Bachelor of Science - Pharmacy
Maharashtra College of Pharmacy
Nilanga, Maharashtra07.2018
Skills
- MedDRA coding
- E2B submission
- Signal detection
- Regulatory compliance
- Process improvement
- Risk assessment
- Adverse event reporting
- Safety reporting
- Adverse event coding
- Safety narratives
- Safety guidelines
- GVP Modules
- Submission guidelines
- ICH-gCP guidelines
Affiliations
As a Drug Safety Professional, I want to grow and make a real difference in healthcare by:
• Learning more about how to detect and manage drug safety risks
• Getting special training and certificates in drug safety rules
• Finding new ways to make medicines safer for people
• Staying updated on the latest research in clinical safety
• Working towards becoming a leader in drug safety
Certification
- Advanced Post Graduate Program in Clinical Research and Management (Clini India)
- Signal Detection and Management in Pharmacovigilance (PV Drug Safety Academy)
Disclaimer
I, Dipak Reddy, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.
Timeline
Senior Drug Safety Associate
Tata Consultancy Services (TCS)
05.2024 - Current
Drug Safety Associate
Qinecsa solution (bioclinica)
04.2021 - 05.2024
Master of Science - Pharmacy
Channabasweshwar Pharmacy College
Bachelor of Science - Pharmacy
Maharashtra College of Pharmacy
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