Priyesh Shabdalu
Senior Drug Safety Associate / Case Specialist
About
Senior Pharmacovigilance professional with 4.5+ years of experience in end-to-end ICSR processing (spontaneous, solicited, literature, and clinical trial cases). Hands-on expertise in Argus, Veeva Safety Vault, MedDRA, and WHODD. Proven track record in QC, peer review, expedited reporting, narrative writing, seriousness & causality assessment, and mentoring juniors while consistently maintaining 100% quality compliance.
Experience
Case Specialist II - ProductLife Group - Ahmedabad, India
(2022-05)
- Processed end-to-end Individual Case Safety Reports (ICSRs) for spontaneous, solicited, literature, and clinical trial cases.
- Performed MedDRA & WHODD coding, seriousness assessment, causality assessment, and high-quality narrative writing.
- Conducted QC and Super QC reviews, consistently achieving 100% internal quality compliance.
- Handled EudraVigilance (EV) and MHRA downloads, analysis, submissions, and reconciliation.
- Managed follow-up activities and regulatory queries.
- Mentored and trained new joiners, resulting in improved team productivity and reduced QC findings.
Drug Safety Associate - IQVIA - Thane, India
(2021-02 - 2021-11)
- Performed booking, triage, and processing of ICSRs (spontaneous, solicited, and literature) ensuring accuracy, completeness, and regulatory compliance.
- Conducted MedDRA/WHODD coding, seriousness & causality assessment.
- Executed QC & Super QC reviews and mentored new joiners.
Senior Customer Care Executive - Intelenet Global Services - Thane, India
(2017-08 - 2018-08)
- Supported safety case intake, triage, and data entry in accordance with ICH guidelines, FDA, and EU regulations.
- Reviewed patient medical records and coded medical history & concomitant medications using standard dictionaries.
- Managed safety mailboxes, follow-ups, and queries.
- Maintained confidentiality and ensured adherence to data privacy and security protocols.
Education
Master's - Clinical Research - Institute of Clinical Research India (ICRI), Mumbai
Bachelor of Science - Zoology - University of Mumbai
