Operations Specialist 1 (PV & Regulatory Affairs)

HIMA RASAGNA RAKURTY

CALIFORNIA, USA +408-***-****

Email: *************@*****.***

LINKEDIN.COM/IN/HIMA-RASAGNA-RAKURTY

PROFESSIONAL SUMMARY

Certified and highly skilled Senior Drug Safety Associate with over 7 years of experience in clinical and post- marketing pharmacovigilance. Led global pharmacovigilance for various therapeutic areas - delivering audit-ready safety data, zero compliance gaps and streamlined reporting pipelines. Served as Workflow & Follow-up Lead and SME for literature and pregnancy cases while also overseeing quality review activities. Recognized for cross- functional collaboration, training support, quality-driven delivery in high-pressure environment and fully equipped to lead safety operations in a dynamic and global setting.

PROFESSIONAL EXPERIENCE

OPERATIONS SPECIALIST 1 (FOLLOW-UP & WORKFLOW LEAD) Aug 2017 – Apr 2021 INDIVIOR PLC, USA (IQVIA INDIA Pvt Ltd.)

Key responsibilities: Executed my job as a workflow and follow-up lead, SME (subject matter expert) of literature, autopsy & pregnancy (PCFR) cases and senior quality reviewer. Managed and co-led the team with safety reporting, following up consumers and healthcare professionals, media review, final case review, QC checks, translation requests, engaged in operations calls, internal and external audits, etc.

• Led case triage, allocation, EOD/weekly/monthly safety reports enhancing workflow efficiency and ensuring timely submissions.

• Maintained consistent client engagement through proactive communication, enhancing satisfaction and trust.

• Conducted SAE reconciliation between clinical and safety databases to ensure data accuracy and compliance.

• Expertise with case processing for different types of cases like literature and PCFR (patient child fetus report) cases, serious and non-serious spontaneous, E2B cases, upgraded and downgraded cases in follow up, Regulatory Authority cases, news article cases, invalid literature and animal cases in Argus and ARISg with full MedDRA and WHO-DD coding.

• Authored high-quality safety narratives, ensured adherence to regulatory, SOP documentation, training logs and audit preparedness.

• Conducted comprehensive literature screening for signal detection, enabling informed regulatory submissions and enhancing safety monitoring.

• Performed case intake, duplicate check, seriousness assessment and full medical data entry.

• Collaborated with sponsors and stakeholders via calls/emails on safety data, SDEA conventions and TAT compliance.

• Supported periodic, aggregate report development (PBRERs, PSURs) and Ad-Hoc regulatory submissions.

• Coordinated cross-functional trainings for new hires, fostering knowledge sharing, improving overall team performance in PV workflows, complex narrative writing and literature case processing.

• Reviewed case quality, conducted sample QC checks and prepared CAPAs for deviations.

• Managed monthly case closure and deletion activities.

• Responsible for query reply management in Argus as Follow-up lead, version creation (handling cases in both fast track and global work flow of safety database).

• Led follow-up activities with HCPs, patients and coroners through multi-channel communication.

• Ensured alignment with ICH-GCP, 21 CFR FDA and EMA guidelines throughout safety operations.

• Acted as workflow lead and supported translation management and protocol configurations.

• Assisted with toxicology report processing, listedness assessment and safety documentation updates.

Achievements: Awarded for quality, productivity, expertise in complex literature/pregnancy cases, Argus queries and backup managerial activities. Earned consistent recognition through appreciation emails by management and clients.

SENIOR DRUG SAFETY ASSOCIATE Apr 2014 – Jul 2017

MERCK & Co., Inc, USA (BIOCLINICA INDIA Pvt Ltd.)

Key Responsibilities: Hired as a Drug Safety Associate and promoted to Senior DSA within one year based on performance excellence. Responsible for the intake, data entry and quality review of adverse event reports in accordance with company Standard Operating Procedures (SOPs), internal protocols and global regulatory guidelines, ensuring full compliance with international pharmacovigilance standards and corporate policies.

• ICSR processing of all case types (clinical, post-marketing, spontaneous, literature, SUSARs, E2B and PCFR) with full lifecycle ownership - from intake to regulatory submission.

• Conducted triage, seriousness assessment, causality evaluation and expedited reporting of adverse events in compliance with ICH-GCP, 21 CFR FDA, EMA and company SOPs.

• Performed SAE reconciliation between clinical and safety databases to ensure data consistency and accuracy.

• Applied MedDRA and WHO-DD standards for coding of medical history, events, labs and concomitant medications.

• Authored medically sound and compliant safety narratives, enhancing the quality of global regulatory submissions.

• Utilized IME and CTCAE criteria to assess seriousness and expedite case evaluation for regulatory reporting.

• Evaluated lists using PI, IB, SmPC and CCDS references to support precise regulatory classification.

• Conducted quality reviews and peer checks, raising case accuracy and audit readiness while minimizing compliance risks.

• Reviewed SUSARs, IND Safety Reports and medically significant ICSRs; supported masking of patient details and urgent classification.

• Generated Cognos reports, updated ARISg journals and tracked KPIs to improve compliance and operational visibility.

• Supported aggregate reporting (DSURs, PADERs) and AOSE (Analysis of Similar Events) for regulatory and signal detection purposes.

• Ensured timely acknowledgments and “Day Zero” determinations for ICSRs under global reporting guidelines.

• Resolved data discrepancies through proactive query handling, communication with affiliates and safety oversight.

• Contributed to SOP revisions, compliance audits and system validations to uphold pharmacovigilance excellence.

• Led refresher trainings, onboarded new team members, promoting consistent case quality and operational efficiency.

Achievements: Promoted to Senior DSA within one year for high-quality delivery, zero escalations and full client compliance; received multiple performance incentives. Collaborated with client to resolve safety process gaps, leading to improved safety protocols and operational efficiency. Earned final commendation for maintaining a flawless client relationship.

Therapeutic areas covered during employment: Opioid dependence & drug addiction, Cardiology, Fertility, Central nervous system (esp. Multiple sclerosis), Endocrinology, Rheumatology, Immunology, Allergopharma, Oncology, Diabetes, etc.

PROFESSIONAL DEVELOPMENT, PERSONAL PURSUITS & WORK AUTHORIZATION PROCESS Jan 2022 – May 2025

Awaited work authorization clearance due to immigration procedures. Utilized this period to upskill through certifications in pharmacovigilance, including aggregate reporting, AI in PV, risk management and signal detection. Actively engaged in shadowing experienced professionals to gain practical insights and stay aligned with drug safety standards. Additionally, continued my 6-year dedicated practice of Indian classical dance, Kathak - delivering private tutoring and successfully completing formal exams at various levels while advancing through performance-level training. This period contributed meaningfully to both professional development and personal discipline.

SKILLS & CORE EXPERTISE

Project Management Tools: Argus 8.1.1 (Oracle) ARISg 7.0 MedDRA 28.0 WHO-DD 21 CFR FDA/EMA Regulations Signal Detection Aggregate Reporting (PBRER, PSUR) SAE Reconciliation Literature Screening IRT [Inbound Receipt Triage] AGXchange GCP/ICH guidelines US FDA and EMA regulations.

Digital Workplace Tools: Microsoft Suite Access SharePoint Project.

Professional Competencies: Training & Team leadership Problem-Solving Analytical Thinking Agile Mindset Client- Focused Sound Decision-Making Results-oriented Relationship Management Adaptability to Change Self-aware Time Management Calmness under pressure Active Learner Excellent communication, presentation and documentation skills.

CERTIFICATIONS & TRAININGS

• Pharmacovigilance Certifications Bundle Jan 2025 – May 2025

(Aggregate reporting AI in PV Signal Detection Risk Management Plan)

• Live shadowing of Aggregate Reporting, Clinical Data Management Jan 2024 – May 2025

• Regulatory (ICH-GCP) and GVP guidelines Jan 2023 – Mar 2023

• ARISg, ARGUS safety database MedDRA Citrix Training Jan 2019 – Feb 2021

• Advanced Diploma in Clinical Research, CDM, PV & Medical Writing Jan 2013 – Jun 2013

• Bioanalytical Research, Indian Institute of Chemical Technology, India Nov 2012 – Oct 2013

• LC-MS-MS Bioanalytical Training, Piramal Healthcare, India Oct 2013 – Dec 2013

EDUCATION

MASTER'S IN PHARMACEUTICAL ANALYSIS AND QUALITY ASSURANCE Jun 2011 – Jan 2013 College of Pharmaceutical Sciences INDIA

Grade/CGPA - 9.53/10 • Academic excellence award recipient and topper of college among all specializations BACHELOR OF PHARMACY Jun 2007 – Mar 2011

College of Pharmaceutical Sciences INDIA

Grade/CGPA - 8.81/10 • Recipient of National Scholarship for master’s degree through Graduate Aptitude Test (GPAT) with All India Rank 2,970

HOBBIES

Volunteering, Event Planning, Reading, Travelling, Classical Dance (Kathak), Yoga and Meditation.

ACHIEVEMENTS & VOLUNTEERING

• GPAT qualified with AIR 2,970 (2011).

• J.N. Das Memorial Award – Honored as graduation topper for highest academic performance in the college.

• College topper in Masters.

• Distinction in senior degree (Nritya Vibhakar -I) classical Indian Dance Kathak.

• Volunteering activities like URDES-India, Age Help India, Red Cross Blood Bank, Action Aid and Second Harvest.

Contact this candidate