Nethravathi Janardhanaiah
Summary
Dynamic and results-driven professional with extensive experience across pharmacovigilance, regulatory inspections, quality assurance, and medical device compliance. Proven track record of leading teams, driving process improvements, ensuring regulatory compliance, and implementing innovative solutions, including AI-driven vigilance systems. Expertise spans drug safety assessment, CAPA management, audits, adverse event monitoring, and cross-functional collaboration across multiple therapeutic areas and global markets. Recognized for operational excellence, team leadership, and consistent performance awards.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Supervisor, Medical Events Group
Abbott Diabetes Care
Alameda
06.2021 - 09.2024
- Contributed to the development and implementation of AI tools for vigilance activities, improving case processing efficiency and data quality.
- Led a team of 17 Medical Events Specialists, ensuring timely and accurate submission of vigilance reports to global Competent Authorities.
- Managed onboarding and training of new hires, enhancing team knowledge and operational efficiency.
- Conducted regular performance reviews, providing constructive feedback and setting actionable goals.
- Supported regulatory inquiries and ensured compliance with international reporting standards.
- Participated in CAPA activities, including initiating non-conformances, assisting investigations, implementing corrective actions, and performing effectiveness checks.
- Provided support for internal and external audits, ensuring adherence to regulatory and quality standards.
- Coordinated with cross-functional teams on documentation and vigilance-related activities to streamline workflows.
MEDICAL EVENTS SPECIALIST - II
Abbott Diabetes Care
Alameda
06.2018 - 05.2021
- Assessed reportability, authored, reviewed, and filed submissions for reportable events and malfunctions to global Competent Authorities, adhering to international regulatory standards.
- Worked closely with Customer Service, Complaint Investigations, and Complaint Evaluation teams to gather data and ensure accurate vigilance reporting.
- Trained and mentored new hires in the Medical Events Group, strengthening team knowledge and capability.
- Supported internal and external audits to demonstrate compliance with medical device regulations.
- Managed Reportable Confirmed Malfunction List (RCML) cases, ensuring timely and accurate reporting.
Professional Development / Career Break Sept 2024
Career Break
10.2024 - 09.2025
- Took a personal career break for family reasons. Maintained industry knowledge through self-study, online courses in pharmacovigilance, regulatory compliance, and AI in PV. Prepared for re-entry into PV, QA, and regulatory roles.
SAFETY REVIEW SPECIALIST (contractor)
Baxter
Deerfield
05.2015 - 08.2015
- Performed literature searches and database queries to identify adverse events for inclusion in the global safety database.
- Coordinated with authors and local pharmacovigilance officers to resolve unclear or incomplete literature data.
- Assessed potential product complaints and reviewed literature case assessments to ensure regulatory compliance.
- Conducted preliminary medical evaluations of literature reports, including pregnancy cases, seriousness, and causality assessments.
- Created valid and invalid safety cases based on reportability and performed data entry in the safety database.
- Executed quality reviews of literature cases to ensure accuracy, completeness, and consistency with global safety standards.
QUALITY ASSURANCE SPECIALIST
Immunoscience Inc.
Dublin
07.2014 - 05.2015
- Led CAPA processes by initiating investigations, performing root cause analysis, and conducting effectiveness checks on non-conformances.
- Managed document control systems, including creation, review, and revision of SOPs, procedures, and forms; maintained Point of Use binders.
- Reviewed and released product batch records, ensuring compliance with manufacturing and quality standards.
- Identified training needs, implemented training programs, and issued document-based training for staff.
- Developed SOPs and supported quality system improvements to enhance compliance and efficiency.
- Participated in internal audits and assisted with QA activities, including preparation of the Site Master File.
DRUGS INSPECTOR [Gazetted Rank]
Government of India, Drugs control Department
Bengaluru
04.2010 - 05.2013
- Conducted audits and inspections of manufacturing plants, storage facilities, and testing processes to ensure compliance with sanitation, purity, and regulatory standards.
- Investigated adverse drug event complaints from consumers, physicians, and pharmacists; reviewed pharmaceutical company PSURs for safety monitoring.
- Evaluated regulatory submissions, recommended label updates, and enforced product withdrawals or suspensions when required.
- Collected and analyzed legal drug samples; inspected retail/wholesale outlets to identify spurious, adulterated, or misbranded products.
- Oversaw pharmacovigilance systems within pharmaceutical companies and investigated illegal pharmacy practices.
- Monitored expired/non-standard drug sales and executed seizure procedures in violation cases.
- Led public awareness initiatives by providing pharmacovigilance information to healthcare professionals, consumers, and media.
DRUG SAFETY ASSOCIATE
IQVIA
Bengaluru
06.2008 - 03.2010
- Assessed adverse events for seriousness, causality, and expectedness per global regulations and SOPs.
- Managed end-to-end case processing, including triage, data verification, narrative writing, and ICSR quality review.
- Applied MedDRA/WHO-Drug for coding; ensured consistency and compliance in safety reporting.
- Oversaw follow-ups, due diligence, literature searches, and expedited reporting for critical cases.
- Trained new associates and delivered refresher programs to enhance compliance.
- Supported diverse therapeutic areas: Oncology, Antifungal, Antipsychotics, Pain, Women’s Health, and Consumer Products.
- Drove process improvement through error analysis and CAPA implementation.
- Conducted risk assessments to identify potential product safety concerns and ensure proactive signal detection.
- Reviewed scientific literature, abstracts, press releases, and FDA advisories to monitor emerging drug safety issues.
CLINICAL DATA VALIDATOR
Symbion Pathology (India) Pvt. Ltd.
Bengaluru
05.2007 - 05.2008
Education
BACHELORS IN PHARMACY -
Rajiv Gandhi University of Health Sciences
Bengaluru03.2007
Skills
- AI Integration for Vigilance & Case Processing
- Pharmacovigilance & Adverse Event Assessment (Seriousness, Causality, Expectedness)
- Medical Device & Drug Safety Reporting (US & ICH Regulations)
- ICSR Management, Literature Review & Quality Case Evaluation
- MedDRA & WHO-Drug Coding
- Regulatory Submissions: IND / NDA, FDA, MHRA, EU MDR
- 21 CFR Part 11 & GMP Compliance
- CAPA Management, Root Cause Analysis & Process Improvement
- SOP Development & Quality System Enhancements
- Clinical Research Process & Pharmacology Knowledge
- Team Leadership, Mentorship & Training
- Proficient in Argus Safety, ARISg, and Microsoft Office
Certification
Certificate - Artificial Intelligence (AI) in Pharmacovigilance
Timeline
Professional Development / Career Break Sept 2024
Career Break
10.2024 - 09.2025
Supervisor, Medical Events Group
Abbott Diabetes Care
06.2021 - 09.2024
MEDICAL EVENTS SPECIALIST - II
Abbott Diabetes Care
06.2018 - 05.2021
SAFETY REVIEW SPECIALIST (contractor)
Baxter
05.2015 - 08.2015
QUALITY ASSURANCE SPECIALIST
Immunoscience Inc.
07.2014 - 05.2015
DRUGS INSPECTOR [Gazetted Rank]
Government of India, Drugs control Department
04.2010 - 05.2013
DRUG SAFETY ASSOCIATE
IQVIA
06.2008 - 03.2010
CLINICAL DATA VALIDATOR
Symbion Pathology (India) Pvt. Ltd.
05.2007 - 05.2008
BACHELORS IN PHARMACY -
Rajiv Gandhi University of Health Sciences
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