Customer Service Quality Control

FAISAL HASSAN

***** ***** ****** ** | Fremont, CA 94538 | Cell: 510-***-**** |email: **.******.******@*****.***

CLINICAL DRUG SAFETY & PHARMACOVIGILANCE

• Health professional offering hands-on experience in Clinical Drug Safety.

• Recognized for consistent ability to ensure continuity of services and exceptional scientific and customer service

• Enthusiastic contributor with a collaborative spirit and a passion for seeing a quality job through to fruition

• Personal strengths include excellent work ethic, self motivated, leader, fast learner, personable, resourceful and excellent organizational skills

• Known for exceptional judgment, efficiency, and project management abilities

PROFESSIONAL EXPERIENCE

Gilead Sciences, Inc – Foster City, CA Aug/10 – present

Senior Safety Specialist – Standards and Collaborations

• Accomplish monthly quality control data checks of randomly selected ICSR’s.

• Quality Control ICSR review to ensure correctness in ICSR Triage, ICSR reporting tools, International submissions, Product information, MedDRA coded terms, Case narratives and Case assessment.

• In depth knowledge of ICSR reporting tools, International submissions and Narrative writing.

• Prepare global monthly performance metrics reports to identify, track and trend reasons for late global incoming and regulatory reports as required per Standard Operating Procedure and Safety Data Exchange Agreements ensuring Drug Safety Compliance with Global Regulatory Compliance.

• Communicate late trends with Adverse Event Management, Pharmacovigilance Responsible Persons, partners and Licensees.

• Prepare monthly internal productivity and workload reports.

• Identify situations and elevating issues that require attention from senior management.

• Maintain compliance with global and local procedural documents and implementation of Standards & Collaborations objectives.

• Train GILEAD personnel on SOP’s and Adverse Event reporting requirements.

• A thorough knowledge of GILEAD products and their associated therapeutic areas.

Tercica/Ipsen Pharmaceuticals – Brisbane, CA April/09 - April/10

Clinical Drug Safety Associate

• Extensively collaborated with Healthcare professionals and Consumers in obtaining follow-up information on reported Adverse Events and product inquiries.

• Dependable Patient monitoring and medical support by providing reliable follow-up.

• Provided detailed training to Healthcare professionals regarding product use as per the US Package Insert and Company Core Safety Information.

• Established meaningful and productive relationships with Healthcare professionals to foster end to end continuity of patient care.

• Maintained a close working relationship with Contract Research Organizations, Medical Information and Clinical Research to establish precedents of information received on each advese event case in accordance to ICH, EMEA and Eudravigilance guidelines.

• Reviewed Clinical and Postmarketing Serious Adverse Events and Adverse Event (SAE & AE) cases for completeness, recognized discrepancies, entered data into safety database (agXchage and ARISg) with accuracy.

• Conducted in-depth scenario analysis including causality assessment, case narrative writing of Clinical and Post-marketed products independently and solely responsible for case follow-up processes.

• Performed internal audit to ensure compliance with Standard Operating Procedures, FDA, and European Drug Safety regulations.

• Maintained a close and dynamic relationship with the Regulatory and Clinical Department.

• Researched and created policies, procedures including ‘Standard Operating Procedures’ for Ipsen which were immediately approved and implemented.

• Proactively identified risks and opportunities and provided recommendations to Ipsen personnel to drive best practices.

• Strengthened Drug Safety Department’s credibility with partners by understanding their specific needs and proactively providing value-added analysis.

• Enhanced the case tracking processes through the creation of improved systems in the design and implementation of safety data management processes to ensure completeness, correctness and consistency of safety data.

• Created a variety of spreadsheets and charts that ensured delivery of quality data outputs for each data acquisition or periodic report within defined timelines.

• Developed various case tracking tools for increased effectiveness of communications to Ipsen personnel and external business partners.

• Prepared various reconciliation reports and presented analysis to Drug Safety Leads on a monthly and quarterly basis.

• Supervised, trained, managed and mentored 2 associates in their career development.

BayView Medical – San Francisco, CA June/02 – Jan/09

Physicians Assistant

• Provided quality patient care by performing precise patient medical history, examination of presenting illness and patient counseling.

• Provided medical consult of patient X-Ray, MRI, and Lab analysis. Performed and analyzed patient vitals, EKG, pulmonary function and lab tests accordingly.

• Successfully supervised and managed 6 physicians in an extremely fast paced clinical practice.

• Diligently maintained patient intake, booking procedures and highly organized records of patient data.

• Management of quality customer service and patient follow-up.

Education

Baqai Medical University 2001

Karachi, Pakistan

M.B.B.S.- Bachelor of Medicine and Bachelor of Surgery

United States Medical Licensing Exam: Step 1 2007

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