概要

A motivated registered Pharmacist with a real passion for healthcare. Excellent track record of maintaining positive relationships with patients, Pharmaceutical representatives, medical professionals, manufacturers, and health care organizations. Ability to advise patients on medication brands, medication storage, adverse effects, and interactions. Able to complete documentation for products registration in DRAP and foreign correspondence.

工作经历

公司标识
Regulatory Affairs Specialist
Abbott Laboratories (Pakistan) Limited
Jul 2021 - 代表 | Rawalpindi, Pakistan

Working as a Regulatory Affairs Specialist at Core Diagnostics Division Islamabad of Abbott Laboratories Pakistan Limited
Responsibilities:

Provide support for Regulatory Affairs related issues to ensure compliance with regulatory requirements & Abbott Quality System regulations.
Maintain Technical Documentation for products.
Provide update and maintain status of product registrations and notifications.
Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions
Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labeling, etc.
Provides support for regulatory processes and procedures.
Maintains current registrations by preparing documentation required and submitting documentation on schedule as directed.
Completes daily work to meet established schedule with guidance from Manager on prioritization of tasks.
Medical and regulatory terminology
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Support and assist the Manager to implement to ensure no business interruption arising from the implementation of the Medical Devices Rules.
Liaise with the International RA Department staff. Implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to.
Liaise with the Abbott Quality Assurance / Regulatory Compliance Departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
 Prepare and submit regulatory files and documentation to Regulatory Authorities in accordance with local regulatory requirements.

公司标识
Quality Assurance and Regulatory Affair Pharmacist
Global Healthcare (Pvt.) Ltd.
Aug 2016 - Jun 2021 | Islamabad, Pakistan

Working as a Quality Assurance and Regulatory Affair Pharmacist at Global Healthcare (Pvt.) Ltd. Pakistan.
Responsibilities:

Foreign Correspondence to complete documentation for registration of products with DRAP.
Preparation of Dossiers.
Work on local regulations for regulatory affairs and compliance management.
Dealing  with external authorities like the Drug Regulatory Authority of Pakistan (DRAP, PQCB)
Quality assurance of products storage, handling, and dispensing.
Product Complain Handling
Revise and update regularly Standard Operating Procedures (SOP) and GDP Protocols.
Focal Person in Coordination for Stock Analysis and Documentation of Warehouse Activities
Coordination with Supply Chain for Replenishment of Stock.
Management of Supply Chain Functions.

公司标识
PHARMACIST
NIBD
Feb 2014 - Mar 2014 | Karachi, Pakistan

Worked as Pharmacist at NIBD (after Pharm D)

公司标识
Quality Assurance Pharmacist.
Ghazi Brothers
Jan 2013 - Dec 2013 | Karachi, Pakistan

Worked as a Quality Assurance Pharmacist.

公司标识
Pharmacy Supervisor
Zubaida Medical Centre
Jul 2012 - Oct 2012 | Karachi, Pakistan

Worked as a Pharmacy Supervisor at Zubaida Medical Centre Karachi

公司标识
Hospital Clinical Pharmacist
Mamon Madical Institute
Jan 2010 - Mar 2012 | Karachi, Pakistan

Worked as a Pharmacist at Memon Medical Institute Karachi.
Major Responsibilities were:

Focal Person in coordination for stock analysis and documentation of the Pharmacy activities
To give pharmacological information for multidisciplinary health care teams and monitor patient drug therapies
Revise and update regularly Standard Operating Procedures (SOP) and Pharmacy Protocols
Coordinating with supply for the replenishment of pharmacy stock

公司标识
HOSPITAL PHARMACIST SUPERVISOR
Institute Of Orthopaedic & Surgery
May 2004 - Dec 2009 | Karachi, Pakistan

Worked as a Pharmacy Supervisor at Institute of Orthopedic & Surgery Karachi
Major Responsibilities were:

In-patient & Out-patient Dispensing of Medicines.
Focal Person in coordination for stock analysis and documentation of the Pharmacy activities
To give pharmacological information for multidisciplinary health care teams and monitor patient drug therapies
Revise and update regularly Standard Operating Procedures (SOP) and Pharmacy Protocols
Coordinating with supply for the replenishment of pharmacy stock
Meetings with Pharmaceutical Representatives.
Floor Stock Management.
Patients Pharmacy Billing.

学历

University of Karachi
硕士, 科学硕士学位, Doctor of Pharmacy‎
B PHARMACY, PHARM-D
CGPA 3.54/4
2013

技能

熟练 Foreign Correspondent
熟练 Handling Assignments
熟练 Legal Compliance
熟练 Pharmaceuticals Administration
熟练 Pharmacy Administration
熟练 Pharmacy Consulting
熟练 Pharmacy Practice
熟练 Regulatory Affairs
熟练 Stock Management
熟练 Supply Management
熟练 Understanding Legal & Scientific Matters

语言

熟练 英语
熟练 乌尔都语