Manager, QREM & Pharmacovigilance

About the role

The Manager QREM & Pharmacovigilance leads product‑related regulatory and quality activities for medical devices and drugs in Pakistan. The role ensures compliance with local health authority requirements, supports market access, and safeguards patient safety throughout the product lifecycle.

Key responsibilities

• Manage medical device and drug registration with DRAP and other authorities, including submissions, renewals and change notifications.
• Maintain and update the Regulatory Information Management System (RIMS) and local registration dossiers.
• Implement and monitor the Quality Management System (QMS) and Regulatory Intelligence System.
• Oversee pharmacovigilance duties as the responsible person, including PSUR, RMP submissions and adverse event reporting.
• Handle customer complaints, product incidents and ensure GMP/GDP compliance in warehousing and distribution.
• Prepare for and support internal and external audits, driving corrective and preventive actions as needed.

Required profile

• Pharmacy, Chemical, Bioengineering or related health professional degree; master’s degree in quality, regulatory or pharmacy is desirable.
• Minimum 8 years of industrial experience in medical devices or healthcare, with strong engagement with health authorities in South Asia.
• Proven ability to lead negotiations with regulators and manage complex registration projects.
• Excellent stakeholder management and communication skills.

Required skills

• Regulatory affairs and pharmacovigilance expertise.
• Knowledge of GMP, GDP, ISO 9001, ISO 13485 (and optionally ISO 31000).
• Proficiency with RIMS, MS Office and ability to adapt to new technologies.
• Fluency in English (written and spoken).