Open to opportunities

shagun punetha

@shagunpunetha

Message

I’m a pharmacovigilance and medical device safety professional delivering compliant ICSR and complaint case processing.

India

Message

What I'm looking for

I’m looking for a role where I can own compliant pharmacovigilance and medical device vigilance case processing, partner with cross-functional quality teams, and keep improving productivity and regulatory-quality outcomes.

I’m a Pharmacovigilance and Medical Device Vigilance professional with 4.5+ years of experience supporting global safety operations. I focus on compliant ICSR processing, MedDRA coding, case intake and triage, and end-to-end workflow execution.

I work extensively in Argus Safety for primary case activities like book-in, validation, data entry, and duplicate detection & reconciliation. I also perform secondary quality control reviews, write case narratives, and manage follow-ups to ensure case completeness and regulatory alignment.

I’m recognized as a Subject Matter Expert (SME) and Mentor, consistently achieving productivity and quality KPIs. In medical device vigilance, I lead complaint handling and post-market surveillance activities, supporting CAPA, Root Cause Analysis (RCA), trend monitoring, and regulatory compliance, including processing 15–16 ICSRs per day with quality scores of 5.0/5.0.

Experience

Work history, roles, and key accomplishments

Senior Executive – Product Surveillance

Baxter India Pvt. Ltd.

Jul 2023 - Nov 2024 (1 year 4 months)

Managed complaint handling and vigilance activities for marketed medical devices in the US market, including complaint intake, triage, due diligence, and reportability assessments. Supported post-market surveillance, CAPA and RCA activities, trend monitoring, and regulatory compliance, collaborating with quality and technical stakeholders during investigations.

Complaint Handling Post Market Surveillance CAPA Regulatory Compliance Due Diligence Triage Investigation Workflow Management Documentation Standards

Drug Safety Associate II (SME-Mentor)

Parexel International Services India Pvt. Ltd.

Apr 2022 - Nov 2022 (7 months)

Processed ICSRs from spontaneous, solicited, and clinical trial sources using Argus Safety, including intake, triage, MedDRA coding, and E2B processing. Performed secondary QC reviews, case narrative preparation, follow-ups for missing information, and mentored junior team members.

ICSR Processing MedDRA Coding Intake Process Triage Secondary QC Review Validation Follow up Workflow Management Mentor

Drug Safety Associate II

Parexel International Services India Pvt. Ltd.

Dec 2019 - Nov 2022 (2 years 11 months)

Performed end-to-end ICSR processing using Argus Safety, including case intake, triage, book-in, data entry, and MedDRA coding. Conducted secondary QC reviews, prepared case narratives, managed follow-ups for case completeness, and supported workflow management, duplicate detection, prioritization, seriousness/causality/reportability assessments; also served as SME and mentor.

ICSR Processing MedDRA Coding Triage Book In Of Cases Data Entry Secondary QC Review Follow up Workflow Management Serioiusness Expectedness Causality Reportability Assessment Regulatory Compliance ICH Guidelines CIOMS Good Pharmacovigilance Practices (GVP)Trackwise Veeva

Drug Safety Associate I

Parexel International Services India Pvt. Ltd.

Jul 2020 - Apr 2022 (1 year 9 months)

Managed end-to-end pharmacovigilance case processing, including follow-up management, quality review, and narrative review, to support submission readiness. Ensured cases met quality and reporting requirements.

Follow up Quality Review Case Review Workflow Management

Drug Safety Associate

Parexel International Services India Pvt. Ltd.

Dec 2019 - Jun 2020 (6 months)

Initiated and processed ICSRs, performing quality checks and maintaining workflow queues to meet pharmacovigilance reporting timelines. Ensured cases complied with required reporting standards.

ICSR Processing Case Processing