Anitha Gurulingappa
Pharmacovigilance Specialist
Dallas
Summary
Results-driven drug safety professional with extensive experience in pharmacovigilance, regulatory compliance, literature screening, and global safety data management. Skilled in case processing, medical coding, quality review, and training. Proven track record across pharmaceutical R&D, retail pharmacy, and global mailbox management. Ready for immediate deployment.
Overview
23
23
years of professional experience
2018
2018
years of post-secondary education
Work History
Pharmacovigilance Specialist I
GlaxoSmithKline India Global Services Pvt. Ltd.
06.2018 - 10.2024
- Conducted literature screening for ICSR and signal detection; developed drug-specific search strategies.
- Supported SERM specialists by identifying relevant safety articles across GSK’s product portfolio.
- Executed surveillance in alignment with regulatory guidelines and company SOPs.
- Triaged, reviewed, and followed up on ICSRs; mentored new recruits and led training programs.
- Drafted training documents and contributed to SOP updates and process improvements.
- Led monthly soft skills programs and participated in team quality checks.
Senior Safety Associate – PV
Norwich Clinical Services (Alvogen Pharmaceuticals)
01.2015 - 06.2016
- Managed case processing, medical coding, narrative writing, and report submissions.
- Functioned as customer liaison for drug-related queries and safety documentation.
- Trained new hires; conducted quality monitoring and CAPA implementations.
- Oversaw mailbox management and lifecycle safety data reporting.
Senior Drug Safety Associate
Synowledge PV Services Pvt. Ltd.
06.2011 - 01.2015
- Handled intake, triage, duplicate checks, and case registration.
- Processed ICSRs and performed medical coding (MedDRA, DRL Code).
- Wrote safety narratives, reviewed cases for accuracy, and conducted quality checks.
- Participated in audits, guided new associates, and ensured SOP compliance.
Pharmacy Associate / Front Desk Associate
Village Pharmacists Inc.
09.2001 - 01.2003
- Delivered customer service, insurance billing, prescription refills, and packaging for senior care.
Education
Advanced Certification in Project Management -
Catalyst Clinical Services
PG Diploma in Clinical Research - Pharmacovigilance
ICRI
AAS - Biotechnology
Montgomery College
01.2005 - 01.2009
Bachelor of Dental Surgery - undefined
MR Ambedkar Dental College
Skills
- Pharmacovigilance
- Regulatory Compliance
- Medical Terminology
- Medical Coding
- Literature Surveillance
- Case Processing
Personal Information
Citizenship: US Citizen
Timeline
Pharmacovigilance Specialist I
GlaxoSmithKline India Global Services Pvt. Ltd.
06.2018 - 10.2024
Senior Safety Associate – PV
Norwich Clinical Services (Alvogen Pharmaceuticals)
01.2015 - 06.2016
Senior Drug Safety Associate
Synowledge PV Services Pvt. Ltd.
06.2011 - 01.2015
AAS - Biotechnology
Montgomery College
01.2005 - 01.2009
Pharmacy Associate / Front Desk Associate
Village Pharmacists Inc.
09.2001 - 01.2003
PG Diploma in Clinical Research - Pharmacovigilance
ICRI
Bachelor of Dental Surgery - undefined
MR Ambedkar Dental College
Advanced Certification in Project Management -
Catalyst Clinical Services
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