Manager Pharmacovigilance and Operations
Since January 2015
Affiliate Safety Representative Phase I-IV, IIS and Company sponsored clinical trials Patient support programs /Marketing research programs Medical writing & publications Compliance with Company Strategy Medical advisory Medical controlling Training Medical Information Collaboration and informational flow
Visiting Lecturer, Clinical Trial Unit
Since October 2014
Clinical Trial Management. Give onsite and offsite classes
Manager Pharmacovigilance & Operations, Medical Affairs Karachi, Sindh, Pakistan
April 2014 --- December 2014
Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
Manager Pharmacovigilance, Medical Affairs
December 2012 --- April 2014
Major responsibilities include providing oversight and direction for all Medical Services and Pharmacovigilance (PV) projects, including SAE management, medical monitoring, clinical event data monitoring committees, and clinical and post-marketing related projects and activities. KOL, advisory boards and clinical operation management. PV and medical science trainings to sales force, staff and external customers. Strategic medical support by ensuring the timely submission and execution of Medical Affair’s projects and successful implementation for key drivers and new launches. Vetting and approval of all promotional materials, patient support information, reminder advertisements and SmPC of the company according to the IFPMA code of conduct and ethics.
Assistant Manager Medical Affairs
November 2011 --- December 2012
Responsibilities include providing scientific information on disease-state background; discussion of compelling current literature; and exploration of current therapeutic treatment options. Initiating and maintaining relationships with external healthcare customers; compliance with legal and regulatory guidelines; providing competitive intelligence; and bringing the science of the drug to the healthcare community. Communicating with both internal and external customers; maintaining records and reports; and managing a territory and customer base queries.Training to sales & marketing on function, disease & products.
November 2009 --- October 2010
Teaching undergraduate medical students, organizing technical skills and coordinating in different events of CME and skills workshops for postgraduate and consultants. I was an active member in compendium meetings for development of undergraduate medical studies.
Resident Medical Officer
December 2007 --- November 2009
Experience in filter outpatient ambulatory clinics, prostate clinics, stone clinics, paediatric urology, stricture clinics and uro-oncology. Responsibilities include managing the admitted patients in the intensive care and ward as well as emergencies. Experience in minor operational techniques like central line insertion, supra pubic catherization, urethral dilatation. I assisted surgical consultants in theatres and outpatient department. I was moderator of Oncology Journal club. Teaching undergraduate and interns. Assisting radiologists, anaesthetics, internists, haematologists, radiation oncologists, infectious disease teams in their clinical procedures and managing patients.
November 2004 --- January 2005
I did my internship in the department of Pediatrics, Emergency room, Neurosurgery and Otolaryngology. My responsibilities included patient care, participation in daily rounds, Journal clubs, Radiology clubs and teaching under graduate medical students.
AdaptabilityOptimismOrganizationInterest in knowledgeTrustSociabilityFlexibilityEfficiencyCritical thinkingCompetitivenessCoordinationCollaborationAuthenticityAnalytical thinkingOrientation
Phase I Scientific writingCAPAClinical operationsClinical trial budgetingClinical pharmacologyFamily practiceWriting Study Procedures and SOPsGeneral practiceClinical trial designKOL managementImmunohistochemistry (IHC)Phases of clinical development (phase I to IV)
Skills and Expertise
Create SOPs Build and manage the Trial Master File (TMF) Monitor a clinical studyCommunicate with investigatorAttend investigator meetingAdverse event reportingApprove patient information
Master of Science (MS) in Drug Development & Clinical Pharmacology from University of Aberdeen in 2011
Certification in Clinical Trial and Regulation from Dow University of Health Sciences in 2010
Bachelor of Medicine, Bachelor of Surgery (MBBS) in Medicine from Sind Medical College, University of Karachi in 2004
Associate’s Degree in Pre-Medicine/Pre-Medical Studies from Adamjee Government College in 1998
Training and Certification
Basic Laboratories Techniques & Ettiquettes Certification