Santhosh Kumar R
Bangalore
Summary
Senior drug safety associate with three extensive experience in Pharmacovigilance, specializing in end-to-end Pharmacovigilance (PV) activities, including ICSR case processing and quality checks for post-marketing and literature case reports. - Skilled in training, case allocation, and providing backup support to ensure seamless operations. - Currently working with the clinical trial team, gaining hands-on experience in triage and case processing for clinical trial-related safety data.
Overview
3
3
years of professional experience
Work History
Senior Drug Safety Associate
Accenture Solutions Pvt. Ltd.
05.2024 - Current
- Conducted quality checks on post-marketing and literature case reports, ensuring compliance with regulatory standards
- Performed trend analysis of errors, identified root causes, and delivered refresher sessions to improve team performance
- Recorded and analyzed process deviations, implementing corrective actions to enhance process efficiency
- Collaborated with AI Bot teams to ensure quality control of AI-processed cases
- Acted as a backup for the training team, allocating cases and conducting training sessions for team members
- Investigated late cases and performed root cause analysis (RCA) to prevent future errors
- Currently working with the clinical trial team, gaining hands-on experience in triage and case processing for clinical trial-related safety data
Drug Safety Associate
Accenture Solutions Pvt. Ltd.
02.2022 - 04.2024
- Prioritized and entered serious and non-serious cases into the global safety database, ensuring compliance with SLA and regulatory deadlines
- Generated FDA MedWatch forms, CIOMS-I forms, and other regulatory documents for European markets
- Consistently coded medical history, lab data, drugs, and adverse events using MedDRA dictionaries
- Identified and resolved ambiguous medical terms, generating coding queries to ensure data clarity
- Authored safety narratives for various case types, including serious, non-serious, literature, and regulatory cases
- Processed E2B cases (serious and non-serious) through E2B import, maintaining high accuracy
- Managed the triage unit, conducting case assessments for expectedness, causality, and expedited reporting
Clinical Lecturer
JSS College of Pharmacy
Ooty
- Published research papers in peer-reviewed journals, contributing to advancements in pharmacotherapeutics
- Delivered lectures and workshops to undergraduate and graduate students, fostering a stimulating learning environment
- Mentored students in academic projects and internships, providing valuable insights and support
- Designed and implemented a new pharmacotherapeutics curriculum, improving student engagement
- Collaborated with faculty to develop course materials and learning objectives aligned with institutional standards
Education
Doctor of Pharmacy - Pharmacy
KMCH COLLEGE OF PHARMACY
Coimbatore12-2018
Skills
- MedDRA coding
- E2B case processing
- FDA MedWatch forms
- CIOMS-I forms
- Pharmacovigilance databases
- AI-based case processing tools
- Advanced excel
- Power BI
- Team management
- Training and mentoring
- Communication
- Problem-solving
- Root cause analysis (RCA)
- Drug safety regulations
- Database management proficiency
- Case processing
- Clinical trial experience
- Pharmacovigilance expertise
- Team leadership qualities
- ICH-gCP guidelines
- Regulatory compliance
- Risk management strategies
- Scientific literature review
- Project management capabilities
Publications
- Dr. Santhosh R, Jayaram S, Rymbal E, Sugumar D. Using Link and Major System of Memory to Memorise, Remember and Recall Pharmaceutical Sciences Better. Indian Journal of Pharmaceutical Education and Research.
- Dr. Santhosh R and Ponnusankar, S. Aluminium Phosphide (Slow) Poisoning: A Narrative Case Review. International Journal of Scientific & Technology Research.
- Dr. Santhosh R, Dr. Deepalakshmi M, Sajna S.J. Knowledge, Attitude and Perception of Pharmacist & Physician Towards Generic Drug Use - A Cross Sectional Study. International Journal of Scientific & Technology Research.
Areas Of Excellence
- Triage and Data Entry: Managed triage processes and performed accurate data entry for pharmacovigilance reports.
- Writing Safety Narratives: Authored detailed safety narratives for adverse drug reactions, ensuring compliance with global regulatory standards.
- Quality Review: Conducted rigorous quality reviews to ensure the accuracy and completeness of pharmacovigilance documentation.
- Training and Mentoring: Provided training and mentoring to team members on pharmacovigilance practices and regulatory requirements.
- People Management: Effectively managed and supervised team members, fostering a collaborative and high-performing work environment.
Timeline
Senior Drug Safety Associate
Accenture Solutions Pvt. Ltd.
05.2024 - Current
Drug Safety Associate
Accenture Solutions Pvt. Ltd.
02.2022 - 04.2024
Clinical Lecturer
JSS College of Pharmacy
Doctor of Pharmacy - Pharmacy
KMCH COLLEGE OF PHARMACY