Regional Risk Management Director
Pharmamed
Total years of experience :17 years, 1 Months
Accomplishments:
• Played a key role in designing and implementing risk mitigation strategies to ensure the safe and appropriate use of cancer medications that cause teratogenic effect on unborn children.
• Founder of a custom fit risk management program for the Levant region (Lebanon, Syria, and Jordan).
• Spearheaded development and management of Risk Management Program (RMPs), ensured regionally aligned principles and standard practices for risk management are consistent with global risk management policy and global benefit-risk assessment.
Key Responsibilities:
• Developing and implementing risk minimization measures / tools in support of risk minimization programs.
• Facilitating risk identification/assessment, establishing annual risk based audit plan, identifying areas of potential internal control exposure and improving operational efficiency.
• Implementing risk assessment policies/procedures, ensuring early detection of possible risks and undertaking effective corrective actions/reporting of the same.
• Chairing meetings and providing regular updates/reports to the Senior Management, tracking success measures and identifying strategies to mitigate risks and avoid change derailers across all elements of the plan.
Accomplishments:
• Instrumental in implementing the quality management system on Good Distribution Practices (GDP) in compliance with European Union Standards and World Health Organization Standards.
• Defined QMS that is commensurate with the complexity of the company’s activities, Proffered regional level support for establishment and oversight of appropriate risk based audit programs.
• Functioned as expert consultant for compliance related issues including interpretation of global regulations and requirements to support implementation into a strategy for sub-distributors across the Levant area.
• Championed QC/QA operations, validation, qualification as well as establishing CAPA process aligned risk management process.
Key Responsibilities:
• Defining and delivering the Quality Strategy on an annual basis as well as ensuring KPI's are monitored, reviewed and achieved on a monthly basis.
• Approving quality control procedures, formulating and managing the development and implementation of goals objectives policies procedures and systems pertaining to the quality control and regulatory functions.
• Auditing processes for compliance, accuracy and conformance to meet international standards. Determining and initiating system improvement cycle, defining problem and designing mistake proofed improvement action plan.
• Directing the investigation team to carry out root cause analysis and CAPA on account of external complaints. Facilitating improvements that impact on product quality, safety, efficiency, performance and throughput.
• Serving as Responsible Person, safeguarding product users against potential hazards arising from poor distribution practices. Ensuring that the conditions of the wholesale dealer’s license are met, and the guidelines of Good Distribution Practice are complied with.
• Proffering strategic guidance for the implementation & maintenance quality management systems based on best practice. Ensuring that any additional requirements imposed on certain products by national law are adhered to.
• Defining responsibility and authority for ensuring optimum implementation of quality systems as well as accuracy and quality of records.
• Playing a key role in planning, execution and implementation of initial and continuous training programs.
• Dexterously executing any recall operations for medicinal products; ensuring that relevant customer complaints are dealt with effectively.
• Authorized to approving any subcontracted activities which may impact on GDP.
• Promoting rigorous adherence to approved processes and requirements including approval of suppliers and customers.
• Performing and responsible for periodic self-inspections following a prearranged program and necessary corrective measures are put in place.
• Deciding on the final disposition of returned, rejected, recalled or falsified products as well as approving any returns to saleable stock.
Accomplishments:
• Coordinate and participate in clinical research studies on breast cancer conducted by principal investigator(s). Managed collection, compilation, documentation and analysis of clinical research data.
• Compiled clinical test results and prepared Case Report Form (CRF) for each participating patient.
The abstract of this study was presented in EMEA Congress on breast cancer.
Key Responsibilities:
• Coordinated and implemented procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation.
• Ensured compliance with protocol guidelines and requirements of regulatory agencies; identified problems and/or inconsistencies.
• Monitored patients' progress to include documentation and reporting of adverse events.
Key Responsibilities:
• Conceptualized and implemented strategic/ tactical business strategies to support organizational sales activities, drive growth and revenue/ profit achievement for a range of pharmaceuticals, consumer health
products and medical equipment.
• Explored new business opportunities, provided strategic guidance on new product introduction and sales promotional events & campaigns.
• Identified and prioritized attractive market opportunities by recognizing and analyzing market segments, market size, industry trends, competition, product usage and profit potential.
• Provided leadership/ strategic direction to MRs to achieve performance objectives, enhance employee productivity and product knowledge through trainings, mentoring & utilization of resources aligned with organizational vision.
Previous Professional Experiences:
• July 2008 - Dec 2009: Internship on Climate Change & Arab World - IndyAct; NGO
Participated in “Arab World Climate Campaign” lead by IndyAct and the alliance of organizations from the
region. The objective behind this campaign was to produce a regional declaration on global climate change
policy that will be submitted to the league of Arab States.
• Jun 2005 - Aug 2005: Field Training, Environmental Health, Safety and Risk Management Center at AUB.
The Training includes activities concerning sanitation, occupational health and safety, management of Domestic and Hazardous Waste at AUB and AUH.
• Aug 2004 - Dec 2004: Internship: Child Abuse and Gender Based Violence - WHO
Received a certificate in recognition of my work performed on Child Abuse and Gender Based Violence campaign.