Oudah Alabdali

Experience

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  Ministry of Health Saudi Arabia

  Jul 2008 - Sept 2009

  Outpatient pharmacy supervisor
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  University of Hertfordshire

  Jul 2010 - Jun 2012

  Full Time Student ( MSc )
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  Royal Commission for Jubail and Yanbu

  Apr 2013 - Feb 2015

  Medication Safety & Quality Officer

  * Fulfilled pharmacy operational requirements by directing workflow to technician. Verifiedpharmaceutical labeling, order entries, charges, and inspections.* Analyzed data of medication errors and adverse drug reactions.* Anticipated legislation and advised management on essential measures to improve. Adheredto infection control protocols.* Improved pharmacological knowledge of hospital employees by contributing to clinicalprograms, training healthcare professionals, students, and residents.* Followed established departmental policies, procedures, and objectives, continuous qualityimprovement objectives, and safety, environmental, and/or infection control standards. عرض أقل

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  CINFA

  Mar 2017 - Sept 2018

  Pharmacovigilance Consultant/QPPV

  * Managed customer interface and communication for assigned projects/programs. RepresentLife cycle Safety on projects/programs; serve as primary point of contact within Life cycleSafety for all internal and external customers; liaise between internal/external customers andLife cycle Safety Service Delivery Team members in Service Operations (SO).* Managed customer deliverable for assigned projects/programs. Tactical, day-to-day customerfacingleadership at project/program level. Responsibilities include project planning (timelines,deliverable), scope management, quality management and project financial management.* Provided leadership structure for customer service interface from scoping stage, throughproposal generation, bid defense to service delivery, and throughout development andcommercial life cycle of product.* Oversaw client and internal audits and inspections for assigned projects, participating asrequired. Liaise with Quality Assurance staff and management in compilation of correctiveaction plans. عرض أقل

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  Arriello

  Jul 2018 - May 2022

  QPPV / LCPPV

  * Provided support with local implementation of risk minimization measures (e.g., identification ofdistributors for Direct Healthcare Professional Communication, assistance with translation,revision, and submission of local educational materials, etc.).* Provided leadership for Pharmacovigilance systems and reports (PSSF, PSMF, PSUR).* Coordinated and reviews of organization-wide adverse drug reaction and medication errorreporting programs.* Determined, coordinated, and scheduled appropriate assignments of medication safetyofficers to meet workload demands.* Conducted research and contribute to literature on medication safety. عرض أقل

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  PrimeVigilance

  Aug 2018 - May 2022

  LocalQualified Person for Pharmacovigilance (QPPV)

  Tasks may include:* Collected and assessed safety information and regulatory intelligence through performance ofpharmacovigilance (PV) activities at local (national) level, ensuring compliance withapplicable local regulations and requirements and acting as point of contact for localRegulatory Authorities (RA) with regards to PV.* Maintained, on ongoing basis, up-to-date knowledge and thorough understanding of regionaland national regulatory and PV legislation (e.g., Adverse Drug Reaction (ADR) reporting rules)as relevant to comply with regional and national obligations.* Monitored on periodic basis of local literature, and cooperation with international team for* screened specific literature under LPV supervision and reconcile monthly.* Developed customer relationship, into partnership mode; manage accounts targeting extendedbusiness relationship throughout life cycle. Focus on customer loyalty and contract renewal.* Facilitated discussions on new business opportunities with existing customers.* Incorporated strategic options when defining project/program scope and processes withcustomer. عرض أقل

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  Oudah Alabdali for PV Services & Consultancy

  Dec 2019 - now

  PV Consultant & QPPV
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  IntuVigilance Limited

  Apr 2020 - now

  PV Consultant

  * I'm assisting in both establishing and managing the pharmacovigilance system, assuring an agile and responsive safety monitoring environment. * Expert for meticulous preparation and ongoing maintenance of the PSMF, providing you with an always up-to-date and regulatory-compliant record. * Oversee and facilitate precise reporting of Adverse Drug Reactions (ADR), product quality complaints, and crucial medical information pertinent to pharmaceuticals and medical devices.* I'm providing a clear and actionable regulatory advice on stipulations, requisites, advertising protocols, and validating medical claims, ensuring your product and practices align with evolving standards. عرض أقل

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  Waymade PLC

  May 2021 - May 2023

  QPPV / LLM / Reg. Intel.

  * Promoted, maintained and improved compliance with legal pharmacovigilance requirements.* Oversight over functioning of company's quality system, such as standard operatingprocedures SOPs, CAPAs, documents control, etc. proper conduct of pharmacovigilanceactivities.* Contacted point for pharmacovigilance inspections.* Oversaw and provided input into regulatory action plans in response to emerging safetyconcerns (e.g., variations, urgent safety updates, and communication to patients andhealthcare professionals (DHCPs). عرض أقل

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  Parexel

  Oct 2021 - now

  Pharmacovigilance Consultant

  * Case processing.* Oversight of CRO of pharmacovigilance activities.* REMS and risk/benefit analysis.* SOP/Work instructions development for pharmacovigilance activities.* Clinical trial and post market case processing.* CRO oversight of safety related activities.* Global aggregate safety report preparation.* Development of Risk Management Plans/REMS and Risk/Benefit analysis.* SOP/Work instructions development for clinical trial safety/pharmacovigilance activities.Strategic consulting عرض أقل