Summary
Overview
Work History
Education
Skills
Certification
Timeline
GeneralManager
Nabeel Khan

Nabeel Khan

Pharmacovigilance Scientist
Coventry,WAR

Summary

A highly skilled pharmaceutical professional with extensive experience in pharmacovigilance, drug safety, and regulatory compliance. Proven expertise in PV quality management systems, strategic oversight of PV processes, and successful management of PV audits and health authority inspections. A polished communicator adept at working across functions, problem-solving, and ensuring regulatory compliance. Excels in leadership, adaptability, and strategic decision-making, with a passion for advancing drug safety initiatives in a dynamic environment

Overview

10
10
years of professional experience
1
1
Certification

Work History

Pharmacovigilance Officer

Cambridge University Hospitals, NHS
05.2023 - Current
  • Improved pharmacovigilance database efficiency by supervising data management, analysis, and staff training, leading to a 20% boost in team performance.
  • Acted as the primary point of contact for serious adverse event (SAE) reports, optimizing communication and reporting workflows, and cutting response times by 15%.
  • Achieved 100% accuracy in coding and prioritizing SAE reports while maintaining full compliance in SUSAR reporting to regulatory authorities.
  • Assisted in generating trial reports, conducting SAE-AE reconciliation, and overseeing safety data monitoring, identifying key trends to enhance early safety signal detection.
  • Collaborated with clinicians, stakeholders, and industry representatives to refine safety review processes.
  • Secured certifications in GCP, GVP, and MedDRA to strengthen expertise.
  • Directed ICSR processing, formalized ICH-GCP guidelines, and executed audits, driving a 15% improvement in productivity and regulatory compliance.
  • Processed over 100 ICSRs monthly, maintaining 100% adherence to MHRA reporting timelines.
  • Shortened SUSAR reporting times by 20% through process enhancements and automation of reporting templates.
  • Led a process re-engineering project to improve and streamline end-to-end service operations, reorganizing communication across five departments and reducing paperwork by 75%.
  • Executed critical internal audits, enhancing regulatory compliance and decreasing safety discrepancies by 15%.

Pharmacovigilance Administrator

Oncology Clinical Trial Office, University of Oxford
03.2022 - 05.2023
  • Company Overview: England, UK
  • Oversaw critical department operations, acted as the point of contact for serious adverse event (SAE) reports, and communicated key details to team members.
  • Coded, logged, and triaged adverse event reports, ensuring accurate query correspondence with reporting sites based on the nature of events.
  • Drafted detailed case narratives for SUSARs and ensured timely reporting to the UK Competent Authority and Research Ethics Committee.
  • Performed data entry, analysis, and extrapolation of the PV database, filtered relevant data, and trained staff on database usage.
  • Assisted with trial reports, SAE-AE reconciliation, and central monitoring of safety data, analysing patterns and trends for risk mitigation.
  • Collaborated with staff members, industry representatives, safety review clinicians, and stakeholders.
  • Successfully acquired Good Clinical Practices (GCP), Good Vigilance Practices (GVP), and MedDRA.
  • Organized ICSR processing, formalized ICH and GCP guidelines, and conducted audits to ensure optimal productivity and compliance.
  • England, UK
  • Conducted the coding and triaging of adverse event reports, ensuring 100% accuracy in query correspondence and improving reporting efficiency by 15%.
  • Developed and delivered staff training on PV database usage, resulting in a 20% increase in team productivity and improved data accuracy.
  • Led the timely submission of SUSAR case narratives, achieving full compliance with UK Competent Authority and Research Ethics Committee regulations while streamlining reporting processes.

Pharmacovigilance Specialist

ProPharma Group
01.2022 - 03.2022
  • Company Overview: Richmond, England, UK
  • Managed key department operations oversaw data entry for post-market case safety reports and ensured compliance with client standard operating procedures and work instructions.
  • Screened cases and assigned priority criteria, coded suspect concomitant treatment and prescribed drugs by utilizing internal and WHO drug dictionaries.
  • Verified data entries, ensured regulatory compliance, and utilized MedDRA Coder Browser to code adverse events.
  • Drafted medical narratives and assigned MedDRA terms to adverse events in adherence with Argus database.
  • Crafted correspondence for case information and clarifications, drafted and reviewed MedWatch CIOMS and E2B reports for global regulatory agencies.
  • Ensured expedited and routine safety reports, conducted literature research, developed training material, and coached staff members.
  • Richmond, England, UK

Assistant Medical Affairs Manager (MI and PV)

SAMI Pharmaceuticals
08.2015 - 01.2017
  • Company Overview: Karachi, Pakistan
  • I have efficiently managed the processing of both serious and non-serious adverse events, ensuring prompt communication of ICSRs.
  • I swiftly responded to Medical Information inquiries, adhering to internal protocols.
  • Annually, I undertook extensive literature reviews, pinpointing articles vital for signal detection and drug safety assessment.
  • I played a pivotal role in crafting and delivering aggregate safety reports, like Annual Safety Reports and PSURs.
  • My meticulous reconciliation efforts ensured alignment with medical inquiries, product complaints, and adverse events, while always meeting regulatory deadlines.
  • I actively liaised with regulatory bodies, partners, and internal teams on safety matters, and contributed significantly to internal and client meetings.
  • My involvement was crucial in coordinating interdepartmental tasks, such as audits, quality control, and inspections.
  • I reviewed essential study documents, offering key Pharmacovigilance insights and ensuring compliance with safety regulations.
  • I provided administrative backing to the Pharmacovigilance team, upholding regulatory and internal standards, and maintained comprehensive knowledge of company products, representing Pharmacovigilance in team discussions and ensuring seamless inter-departmental communication.
  • Karachi, Pakistan

Education

PhD - Pharmacy Health and Wellbeing

University of Sunderland

Master of Science - Clinical Pharmacotherapy and Medicine Management

University of Sunderland

Doctor of Pharmacy - undefined

Ziauddin University

Skills

  • Pharmacovigilance Operations
  • PV Database Management
  • Good Vigilance Practices
  • Cross-functional Collaboration
  • Regulatory Compliance
  • Safety Audits
  • Adverse Event Reporting
  • Team Leadership
  • Medical Coding & Documentation
  • Good Clinical Practices (GCP)
  • Risk Assessment & Mitigation
  • Automation for PV Database

Certification

  • Good Clinical Practices (GCP)
  • Good Vigilance Practices (GVP)
  • MedDRA Certification
  • Risk Management
  • Signal detection

Timeline

Pharmacovigilance Officer

Cambridge University Hospitals, NHS
05.2023 - Current

Pharmacovigilance Administrator

Oncology Clinical Trial Office, University of Oxford
03.2022 - 05.2023

Pharmacovigilance Specialist

ProPharma Group
01.2022 - 03.2022

Assistant Medical Affairs Manager (MI and PV)

SAMI Pharmaceuticals
08.2015 - 01.2017

PhD - Pharmacy Health and Wellbeing

University of Sunderland

Master of Science - Clinical Pharmacotherapy and Medicine Management

University of Sunderland

Doctor of Pharmacy - undefined

Ziauddin University

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