Summary
Overview
Work History
Education
Skills
Visa Status in Ireland
Certification
Accomplishments
Timeline
Generic

Ebtisama Moghis

Summary

Dedicated Pharmacovigilance Specialist with 3+ Years of Experience in Drug Safety Monitoring, Regulatory Compliance, and Adverse Event Management.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Medical Quality Control

Advanced Medical Services
03.2025 - Current
  • Clinical Data & Compliance Management: Accurately processed and maintained clinical documentation within internal systems, ensuring compliance with regulatory and quality standards.
  • Safety Data Handling: Drafted and reviewed patient reports with a strong focus on accuracy and completeness.
  • Cross-functional Communication: Collaborated effectively with patients, clients, and healthcare professionals via phone and email.
  • Confidential Data Archiving: Maintained and archived clinical data in accordance with data protection and regulatory requirements, ensuring confidentiality.
  • Administrative & Operational Coordination: Oversaw data tracking, managed queries, and rescheduled appointments.

Assistant Manager Medical Affairs

Martin Dow Marker Ltd
08.2023 - 10.2023
  • Managed pharmacovigilance activities, including ICSR identification, collection, and ensuring compliance with global safety regulations.
  • Maintained Safety Data Exchange Agreements (SDEAs) with business partners, ensuring efficient case handling.
  • Conducted monthly line listing reconciliations, prepared safety documents, and facilitated PV training for internal teams.
  • Managed the PV database and archived the Pharmacovigilance System Master File (PSMF) to ensure compliance.
  • Improved audit readiness by enhancing documentation processes, strengthening compliance, and streamlining reporting efficiency.

POP Governance Specialist

Novartis Pakistan
03.2023 - 07.2023
  • Managed safety aspects for Patient-Oriented Programs (POPs), Digital Engagement Assets (DEAs), and Social Media Listening Programs (SMLPs).
  • Ensured compliance with Novartis global/local guidelines by processing Adverse Event reports and managing safety information exchange with Health Authorities and internal departments.
  • Coordinated safety reporting to Health Authorities, monitored National PV guidelines, and facilitated PV training.
  • Strengthened safety compliance, streamlined safety reporting, and ensured efficient documentation and archiving.

Patient Safety Associate

Novartis Pakistan
09.2020 - 02.2023
  • Managed and monitored pharmacovigilance activities across marketed products.
  • Ensured compliance with global/local procedures and international regulatory guidelines for adverse event reporting.
  • Oversaw the collection, processing, and follow-up of adverse event reports, ensuring alignment with global patient safety standards.
  • Conducted audits and reviewed medical records to enhance data accuracy and compliance rates.
  • Maintained regulatory compliance and streamlined pharmacovigilance processes for improved efficiency.

English Teacher

The Academy Schools
01.2020 - 07.2020
  • Developed innovative lesson plans to engage students in English language learning.
  • Assessed student progress and provided feedback to improve performance and establish academic success.
  • Designed and implemented assessments to measure student progress in English language learning.

Education

Doctor of Pharmacy - Pharmaceutical Sciences

University of Karachi
12.2019

Skills

  • SOP Development & Audit Readiness (Regulatory Documentation, Inspection Preparedness)
  • Adverse Event Case Processing (ICSRs, Literature Screening, Spontaneous Reports)
  • Pharmacovigilance Compliance (HA Regulations – DRAP, GVP; Familiarity with FDA, EMA Standards)
  • CAPA & Deviation Management (Corrective & Preventive Actions, Compliance)
  • Training & Compliance Monitoring (Regulatory Training, Compliance Oversight)
  • Cross-Functional Team Collaboration (PV, Medical Affairs, Regulatory Teams)
  • Safety Database Management (ARGUS Affiliate, Veeva Vault)
  • Clinical Data Management
  • Medical Writing (Safety Reports, PSUR)

Visa Status in Ireland

Currently holding a Stamp 1G spousal visa linked to my spouse's Permanent Residency in Ireland; no visa sponsorship required, now or in future. 

Certification

Patient Safety Specialization
Johns Hopkins University – Completed Feb 2025

  • Strengthened strategies for effective communication and teamwork to enhance patient safety.
  • Acquired expertise in designing and leading quality improvement projects.
  • Developed a strategic career plan focused on leadership in patient safety and healthcare quality.
  • Gained proficiency in risk management, project management, and cross-functional collaboration.

Accomplishments

  • I performed audits for Novartis and Martin Dow Marker, focusing on Pharmacovigilance, Patient Oriented Programs, and Medical Affairs. I ensured audit readiness by gathering and organizing necessary documents, maintaining compliance with regulatory standards, scheduling meetings, and managing communication with auditors. I also addressed documentation gaps, ensured timely submissions, and handled responses to audit findings.
  • I contributed to the ICSR project at Novartis Philippines by adhering to both global Novartis standards and local Health Authority (HA) guidelines.
  • President of Humans of Pharmacy in University of Karachi.

Timeline

Medical Quality Control

Advanced Medical Services
03.2025 - Current

Assistant Manager Medical Affairs

Martin Dow Marker Ltd
08.2023 - 10.2023

POP Governance Specialist

Novartis Pakistan
03.2023 - 07.2023

Patient Safety Associate

Novartis Pakistan
09.2020 - 02.2023

English Teacher

The Academy Schools
01.2020 - 07.2020

Doctor of Pharmacy - Pharmaceutical Sciences

University of Karachi
Ebtisama Moghis