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)
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.