Shahabaz Sayyed
Senior Pharmacovigilance Specialist @PrimeVigilance
Signup · Get unlimited contacts
WORK HISTORY
Senior Pharmacovigilance Specialist @PrimeVigilance
Pune, IN
ICSR Processing: Specializes in Individual Case Safety Report (ICSR) processing and submission.ICSR Lifecycle Management: Manages the entire ICSR lifecycle, from triage to final quality review.Diverse Case Types: Experienced in managing various case types, including spontaneous reports, Managed Access Programs (MAP), Non-Interventional Studies (NIS), clinical trials (CT), special situations, pregnancy cases, literature cases, product complaints/malfunctions, E2B, and EVHUMAN cases.Database Proficiency: Proficient in using safety databases such as Arisg, Argus, and LSMV.Narrative Writing: Strong narrative writing abilities to support comprehensive safety assessments and regulatory submissions.Event Labeling: Skilled in event labeling, referencing key clinical sources such as Investigator’s Brochure (IB), Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC), and United States Package Insert (USPI).Aggregate Reporting Knowledge: In-depth knowledge of aggregate reporting requirements, including Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Development Safety Update Reports (DSUR).Regulatory Compliance: Committed to maintaining the highest standards in drug safety and regulatory compliance.Pharmacovigilance Monitoring: Monitored the timely completion of pharmacovigilance activities, including case processing and signal detection.Documentation: Drafted protocols, study reports, and meeting minutes related to drug safety activities.
EDUCATION
Jawaharlal Nehru Technological University
Master's degree
Savitribai Phule Pune University
Bachelor's degree
ABOUT SHAHABAZ SAYYED
Pharmacovigilance Specialist | ICSR Expert | Safety Data Management | SME | Regulatory ComplianceI’m a highly skilled pharmacovigilance professional with extensive experience in processing end-to-end Individual Case Safety Reports (ICSRs) across a wide range of sources and case types—including spontaneous (serious & non-serious), literature-based, clinical trials, post-marketing surveillance (PMS), patient support programs (PSP), non-interventional studies/programs (NIS/NIP), and medical device reports. Core Competencies:Hands-on experience with safety databases such as Argus, ArisG, and LSMV for case intake, triage, book-in, MedDRA/WHO-DD coding, and regulatory compliance.Proficient in authoring high-quality narratives, performing seriousness, causality, and expectedness assessments using IBs, CCDS, SmPCs, and USPI.Managed safety data from multiple sources: EVWEB, EudraVigilance, MLM, PubMed, and internal reporting systems.Skilled in literature screening, signal detection, and analysis using data mining techniques and scientific publications.Authored content for aggregate safety reports including PSURs, DSURs, PBRERs to support global health authority submissions. Leadership & Compliance:Led quality control (QC) checks, case audits, and SOP adherence, reducing rejection rates and improving regulatory inspection readiness.Reported compliance KPIs and case quality metrics to cross-functional teams and stakeholders.Coordinated follow-ups with HCPs/reporters to ensure completeness and accuracy of data.Contributed to benefit-risk evaluations and implemented risk minimization measures (e.g, REMS, RMPs, DHPCs, label updates).Delivered internal training sessions and mentored junior team members in pharmacovigilance best practices.Acted as Subject Matter Expert (SME) during inspections by FDA, EMA, MHRA, ensuring documentation accuracy and traceability. Team & Process Excellence:Spearheaded task allocation, optimized workflows, and drove process improvements, resulting in reduced turnaround time (TAT) and increased efficiency.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.