Headline

Pharmacovigilance Specialist · 7+ Yrs | End-to-End ICSR Processing · ARGUS · ARISg · MedDRA/WHO-DD | Literature Surveillance · Rare Disease · Post-Marketing Safety | Clinical Trials | Lean Six Sigma Green Belt · BDS

About

Pharmacovigilance professional with 7+ years of end-to-end drug safety experience spanning spontaneous, clinical trial, solicited, and literature sources. BDS background delivers the clinical lens that separates accurate narratives from technically adequate ones. Core competencies: ▸ ICSR lifecycle management — intake, triage, MedDRA/WHO-DD coding, narrative writing, quality review, and regulatory submission in Oracle ARGUS, ARISg 5.0, and AgXchange ▸ Literature surveillance — global medical literature monitoring (PubMed, EMBASE) for adverse event identification and signal detection across ophthalmology, rare disease, and pain management portfolios ▸ Aggregate reporting support — trend analysis and verified data contributions to PBRERs/PSURs; audit-ready documentation ▸ Cross-functional compliance — LSO and Regulatory Affairs collaboration ensuring GVP/ICH-E2B(R3) compliance across 40+ countries ▸ Process improvement — Lean Six Sigma Green Belt applied to workflow optimization, SOP development, and new-hire mentoring Currently at ClinChoice (supporting Vertex Pharmaceuticals): selected for the pilot batch of a major US pain management product launch, managing the clinical-trial-to-post-marketing safety transition for a rare disease portfolio. Technical stack: Oracle ARGUS · ARISg 5.0 · AgXchange · SCEPTRE · Eudravigilance · MedDRA · WHO-DD · Microsoft Office

Location

Greater Bengaluru Area

Work experience

Safety Operations at ClinChoice, Sep 2024 - Present · 1 yr 11 mos, Bengaluru, Karnataka, India, Manage end-to-end ICSR processing for rare disease and pain management portfolios in Oracle ARGUS — covering intake, triage, MedDRA/WHO-DD coding, narrative generation, quality review, and regulatory submission. Selected for pilot batch of a new US pain management product launch; overseeing seamless transition from clinical trial safety monitoring to post-marketing pharmacovigilance. Identify medically significant adverse event trends through case-level analysis, feeding signal detection workflows and informing quality review priorities. Serve as point of contact for audit-readiness activities; maintain GVP/ICH-E2B(R3)-compliant documentation in line with FDA, EMA, and global regulatory requirements.

Safety Specialist at ClinChoice, Sep 2024 - Present · 1 yr 11 mos, Manage end-to-end ICSR processing for rare disease and pain management products. Support clinical-trial to post-marketing safety transition for new product launch. Identify case-level safety trends contributing to signal detection workflows. Maintain GVP/ICH-E2B(R3) compliant documentation and support audit readiness. Collaborate with safety physicians and regulatory stakeholders.

Senior Drug Safety Associate at Qinecsa Solutions, Mar 2024 - Sep 2024 · 7 mos, Conducted systematic global literature surveillance (PubMed, EMBASE) for ophthalmology and specialty pharma portfolios, identifying adverse events and potential safety signals per GVP Module VI requirements. Led literature case development and tracking; maintained project management efficiency across concurrent client portfolios with zero critical timeline breaches. Served as QA point of contact for data quality preparation — identifying case-level quality issues, coordinating corrective actions, and monitoring KPIs for continuous improvement reporting. Represented operations in cross-functional project meetings; delivered structured insights on workflow challenges and process optimisation opportunities.

Drug Safety level 2 (Literature reviewer) at Qinecsa Solutions, Apr 2021 - Mar 2024 · 3 yrs, Served as a prime member of the literature case reviewing team, ensuring high-quality standards. Acted as the point of contact for quality data preparation for the Quality Assurance team. Coordinated with clients to address queries and confirm details, enhancing communication efficiency. Monitored quality metrics and shared insights for continuous process improvement.

Drug Safety Associate 2 at IQVIA, Jan 2020 - Apr 2021 · 1 yr 4 mos, Bengaluru, Karnataka, India, • Reviewed and processed serious and non-serious adverse event reports in compliance with global regulations. • Assisted in international pharmacovigilance projects for JANSSEN (Johnson & Johnson) across 40+ countries. • Ensured timely reporting of safety information for ICON, MERK, and other sponsors. • Provided training and support to colleagues as a buddy, enhancing team collaboration.

Drug Safety Associate 1 at IQVIA, Jun 2019 - Jan 2020 · 8 mos, Bengaluru, Karnataka, India, • Triage of incoming cases to prioritize daily workflow management for Janssen pharma drugs. • Performing single case creation/initiation in the safety database • Keeping track of the Product Quality Complaints. • Performing clear and accurate data capture for ICSR including serious and non-serious without or without PQC from spontaneous, solicited and clinical trial, literature and E2B cases with appropriate medical assessment with client conventions and guidelines and SOPs. • POC for the case registration of the AE safety profile for special project Zytiga bolus . • Reviewing Documents, creating case, processing for BOLUS projects like AXA for Janssen pharma drugs. • Excellent working knowledge of MedDRA and WHO-DRUG coding dictionaries

Safety Associate Trainee at IQVIA, Jan 2019 - Jun 2019 · 6 mos, Greater Bengaluru Area, • Investigated and assessed case reports related to the safety of investigational and marketed drugs at Johnson & Johnson. • Reviewed medical literature for adverse event reports, ensuring compliance with FDA and ICH regulations. • Participated in clinical team meetings to discuss safety-related issues and findings. • Developed proficiency in Word-processing, SCEPTRE, AgXchange Database, Adobe, and Spreadsheet tools.

General Dental Surgeon at Dr Nevins Family Dental Clinic, Aug 2018 - Dec 2018 · 5 mos, Kochi, Ernakulam

Resident Intern at KVG Dental College & Hospital Sullia, Sep 2017 - Oct 2018 · 1 yr 2 mos, Sullia DK, Rotatory internship in the hospital attached to KVG Dental College & Hospital, Sullia. • Provided routine and emergency dental cover in conjunction with senior Dentists also involved in various free dental camps and dental check-ups in public health centres. • Supervised the daily clinical management of patients under the guidance of consultants. • Communicate dental problems and other concerns with the Consultant as and when necessary. • Discuss post-operative medication with patients and write a discharge summary.

Education

Bachelor of Dental Surgery, Dentistry, Rajiv Gandhi University of Health Sciences

Bachelor's Degree, Rajiv Gandhi University of Health Sciences