Aswathi M.C
Pharm D
Kozhikode
Summary
Dedicated and detail-oriented Pharm.D professional with over 4.4 years of experience in pharmacovigilance, clinical operations, and medical data review. Currently serving as Operations Specialist I at IQVIA, with demonstrated expertise in case processing, quality review, and medical narrative writing. Proven ability to maintain compliance with global regulatory standards while ensuring data accuracy, integrity, and scientific rigor. Aspiring to transition into a Medical Science Liaison (MSL) role to apply clinical expertise, communication skills, and scientific insight to support evidence-based medicine and stakeholder engagement.
Overview
4
4
years of professional experience
3
3
Languages
Work History
Operations Specialist I
IQVIA
05.2021 - Current
- As Quality Check Reviewer:
- Performed QC review of all processed cases, prioritizing serious cases to ensure compliance with internal policies.
- Reviewed data entered in safety databases for completeness and accuracy.
- Provided quality feedback and maintained quality metrics.
- As Case Processor:
- Responsible for data entry of individual case safety reports (ICSRs) into ARISg Version 7.4.4.0.8.
- Reviewed and evaluated adverse event information to ensure compliance with internal SOPs and global regulations.
- Completed full data entry including medical coding and narrative writing within project timelines.
- As Narrative Writer:
- Drafted medically relevant safety narratives ensuring completeness and accuracy.
- Contributed to database consistency and compliance across pharmacovigilance workflows.
- Achievements
- Selected to participate in internal audit as spokesperson for the Quality Review team, demonstrating deep process knowledge and communication excellence.
- Recognized by auditors and senior management for professionalism and technical expertise.
- Received Employee Recognition Award (2023) for outstanding contribution to quality improvement.
Education
Doctor of Pharmacy (Pharm.D) -
Kerala University of Health Sciences
10.2020
Skills
- Medical Training & Scientific Communication
- Pharmacovigilance Case Processing
- Quality Review and Data Validation
- Literature Review & Medical Writing
- Clinical Trial Operations & Reporting
- Safety Database Management (ARISg 74408)
- Compliance & Regulatory Awareness
- Stakeholder Collaboration & Presentation Skills
- Safety Databases: ARISg
- Tools: Microsoft Excel, PowerPoint, MedDRA Coding
Timeline
Operations Specialist I
IQVIA
05.2021 - Current
Doctor of Pharmacy (Pharm.D) -
Kerala University of Health Sciences