Furqan
Drug Safety Scientist | Expertise in ICSR, Literature Screening | End-to-End PV Operations | Compliance & Risk Mitigation | Post Marketing Surveillance | Argus Testing
- Role
- Drug Safety Scientist at Accenture
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Furqan
I am a seasoned Drug Safety Scientist with 8+ years of experience in the pharmaceutical industry, leading and coordinating global pharmacovigilance activities. I have successfully managed cross-functional safety teams, case processing workflows, contributed to global safety submissions, and driven continuous process improvement.• Comply with Regulatory due dates, turnaround time, Service level agreements and Key performance indicators.• Triage, Case processing and Quality Review of ICSRs before submission of cases to meet the E2B R2/R3 requirements and granularity in accordance to source documents, as and when required for submission to regulatory authority.• Evaluate individual case reports e.g. case receipt, validity check, and triage, determined the seriousness of adverse events, performed labelling, determined drug causality.• Post Marketing Surveillance, Eudravigilance, MHR and XML Handling.• Literature article’s review and screening.• Involved in Reconciliation activity.• Hands-on experience in handling of Argus, ARISg and LSMV safety databases. PubMed/Embase tools.• Sound knowledge of ICH-GCP,GVP Guidelines and Clinical Trails.
Experience
Drug Safety Scientist
Mar 2024 — Present · Bengaluru, IN
Act as a subject matter expert on all PV activities and support quality and compliance.• Lead pharmacovigilance operations, ensuring compliance with global regulatory requirements.• Case prioritizations, allocation and reconciliation of cases based on seriousness and regulatory timelines.• Involvement in resource management along with extra PV related activities.• Prioritising Quality Review for individual case safety report ( ICSR)in accordance with guidelines.• Comply with Regulatory due dates, turnaround time, Service level agreements and Key performance indicators.• Leading pharmacovigilance activities for clinical and post-marketing surveillance.• Develop and implement SOPs for pharmacovigilance processes.• Responsible to perform literature review and literature search.
Education
Jawaharlal Nehru Technological University
Master's degree, Pharmacy
2015 — 2017
Jawaharlal Nehru Technological University
Bachelor's degree, Pharmacy
2011 — 2015
CliMed Research Solutions
Basic Cardiac Pharmacology, Pharmacology
2020 — 2020
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