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Anita User

@anitauser6

Message

I build compliant clinical and pharmacovigilance documentation across EU MDR and global safety requirements.

India

Message

At L&T Technology Services, I author and review CERs, CEPs, PMCF Evaluation Reports, and PSURs while supporting EU MDR compliance, DHF remediation, and product lifecycle documentation.

Previously at Celegence and HCL, I delivered clinical evaluation documentation, systematic literature reviews, gap analyses, audit readiness, and mentoring for junior writers.

Across Norwich Clinical Services and ICON, I managed ICSR processing, MedDRA coding, safety reporting, quality reviews, aggregate reports, and pharmacovigilance databases. I bring 14+ years spanning drug safety, medical writing, regulatory affairs, and clinical research.

Experience

Work history, roles, and key accomplishments

Current

Technical Lead

Current

L&T Technology Services

Jul 2022 - Present (4 years 2 months)

Authored and reviewed Clinical Evaluation Reports, Plans, PMCF reports, and PSURs under EU MDR. Performed DHF remediation, supported QMS processes, and prepared documentation for audits and inspections.

Medical Writing EU MDR Clinical Evaluation DHF Remediation QMS CAPA Change Control Regulatory Compliance Audit Readiness Windchill Teamcenter Agile

Senior Medical Writer

Celegence

Dec 2021 - Jul 2022 (7 months)

Authored and reviewed CER, CEP, PMCF, and PSUR documents in compliance with EU MDR. Conducted systematic literature reviews and supported audit readiness and mentoring of junior writers.

Medical Writing EU MDR literature review Clinical Evaluation Regulatory Compliance Audit Readiness Mentorship

Senior Medical Writer

HCL

Mar 2019 - Dec 2021 (2 years 9 months)

Authored and reviewed CER, CEP, PMCF, and PSUR documents under EU MDR. Performed gap analysis for MDR, ISO 13485, and FDA compliance, and supported PV activities and audit readiness.

Medical Writing EU MDR Gap Analysis ISO 13485 FDA Pharmacovigilance Audit Readiness Mentorship

Senior Safety Associate

Norwich Clinical Services

Nov 2016 - Feb 2019 (2 years 3 months)

Managed pharmacovigilance activities including ICSR case processing, quality review, and regulatory submission. Supported aggregate reporting, signal detection, and trained junior staff.

Pharmacovigilance ICSR Management MedDRA Coding ICH GCP ICH E2B GVP省令 Quality Review PSURs DSURs Signal Detection PV Edge PV Network Training

Medical Affairs Specialists and Drug Safety Associate

ICON

Jan 2013 - Oct 2016 (3 years 9 months)

Managed pharmacovigilance activities including ICSR processing, medical review, and submission. Provided medical affairs support, responded to medical information queries, and coordinated with healthcare professionals.

Pharmacovigilance ICSR Management MedDRA Coding ICH GCP ICH E2B GVP省令 Medical Review PSURs DSURs Signal Detection Argus Emprica Trace Medical Affairs

Clinical Research Coordinator

Fortis Malar Hospital

Dec 2011 - Dec 2012 (1 year)

Coordinated clinical trial activities including patient recruitment, data collection, and protocol compliance. Managed study operations, documentation, and site coordination in accordance with GCP standards.

Clinical Research GCP Patient Recruitment Data Management Protocol Compliance Site Coordination Informed Consent Forms CRF