Clinical Program Management for different clinical trialsSupporting the team for all the timely deliverables

Clinical Program Management for HS Group

Doing Research projects

Zonal Named Safety Contact (Safety Manager) responsible for ensuring the implementation of paramount important system of Pharmacovigilance in GlaxoSmithKlineMonitoring and tracking of all Serious and Non-serious adverse events reported for Marketed and Investigational productsExpedited reporting of adverse events to local Regulatory authoritiesMaintain awareness of the current local pharmacovigilance & materiovigilance requirementsComplete documentation of all safety related informationProvide training to all company employees on adverse event reporting as per the timelinesPeriodic review of the Literature and company sponsored websites for any possible adverse event reportingsMedical liaison officer for different brands in therapy areas like anti-infective, respiratory and metabolicMedical review of all advertising and promotional materialsProvide timely and accurate medical information to internal and external customersClinical & Scientific information provided and shared with the Healthcare professionalsFrequent interactions and development of the KOLs for Advisory Board meetings, Data presentation at any Conference, Symposia and their participation at an international meetingsConducted Continuous Medical Education and Scientific Engagement programsResponsible for ensuring the country Prescribing Information and instructions for use for all of GSK products are kept up to date.Responsible for ensuring operating company has processes in place to comply with local regulations and all appropriate pharmacovigilance SOPs are in place.Lead Commercial team through value added local and regional trials.Successfully implemented GSK Promotion and Marketing Code activities.Spearheaded the clinical trials and Post Marketing surveillances. Assume overall Medical Advisory Function.Negotiation and finalization of Safety Data Exchange agreements with all licensing partners in conjunction with Legal and Regulatory affairs, as appropriate.

Manager Clinical Research in GlaxoSmithKline from 2003 through 2008

Over five years of clinical operations project management and monitoring experience for different phases of clinical programs in diversified therapeutic areas.Responsible for Cost effective clinical trials, quality data and timely completion of the projectsSpearheaded the team of study monitors for clinical programs for various exciting molecules in Oncology, Hematology,Cardiovascular, Metabolic, Neurosciences and Infectious diseases.Manage the delivery of clinical study protocols, clinical study reports, study agreements, applications and other study documentation such as newsletters and study presentations. Lead overall activities and optimize the performance of the study team. Monitor study progress such as patient recruitment and protocol compliance. Study data listings and tables review, including scientific content and data validation. Tracked and managed studies to agreed timeline, budget, materials and resources.Train internal and external study personnel in study specific procedures. Communicate findings to sub-team, clinical development team and pharmacokineticists. Provide scientific input to the development of contingencies, where the emerging data require changes to the program and individual studies. Contracts and good relationships with the vendors Like Quest Diagnostics, Covance and many others

Working as a liaison between site and sponsorResponsible for setting up and reviewing feasibility criteria from different sites and Sites selection.Site staff training on GCP, study Protocol and study related proceduresAchieving ethics committee and regulatory approvals.Lead successful completion of all assigned projects within agreed timelines.Responsible for effective monitoring, Source document verification and data cleaning.Safety reporting to local regulatory and ethics committees, and ensuring proper site closure.

Supported Commercial team for the successful launch of Seretide/AdvairDeveloped Rebuttals and different promotional materials, activities and

Pharmatec Pakistan (Private) LimitedResponsible for the development and implementation of marketing strategies and their execution.Responsible for budgeting, forecasting and product launches.Responsible for the development of product literature.

Worked as clinician (GP) for the period mentioned above.