Associate Director/ Senior Manager, Saudi Arabia

2 weeks ago

المملكة العربية السعودية, Saudi Arabia BeiGene Full time

General Description:


This position is responsible for all aspects of patient safety within Saudi Arabia, as the appointed Saudi QPPV, as well as aspects of individual case safety reporting (ICSR), periodic report preparation, legislation monitoring, periodic literature surveillance and local standard operating procedures.

The Individual will play a significant role in the establishment of the local PV system, in conjunction with Global Patient Safety strategy.

In addition, this individual will play a significant role in the establishment and build of the MENA patient safety system in alignment with the Global Patient Safety strategy.


Essential Functions of the job:
Key Responsibilities

  • Responsible for establishing the national PV system and performance as the appointed Saudi Arabia QPPV.
  • Licensed by Saudi Commission for Health Specialties
  • Acts as the point of contact for all pharmacovigilance enquires from SFDA.
  • Be available to SFDA on a 24hour basis.
  • Maintains knowledge of local and international regulatory requirements, pharmacovigilance science and process best practice.
  • Responsible for ongoing legislation monitoring, subsequent impact assessment and recommendations relating to operational updates/modification across MENA.
  • Accountable to ensure the appropriate pharmacovigilance documents are prepared and submitted to SFDA and across MENA. These include but are not limited to ICSRs, PSURs, ongoing pharmacovigilance evaluations during postregistration period, company sponsored pre
- and post-registration study reports.

  • Responsible for establishing and monitoring local [& regional] communication channels for the exchange of safety information; triages information appropriately across Global Patient Safety and interfacing teams.
  • Ensures any requests from SFDA [or other MENA Regulatory Authority] for additional information deemed necessary for the evaluation of the riskbenefit ration of a marketed product is provided to SFDA the regulator.
  • Monitors the benefit risk profile of assigned portfolio and providing evaluation to the Global Safety Management Team (SMT), or relevant safety governance committee.
  • Provides input into the preparation of regulatory action in response to emerging safety concerns.
  • Meaningfully contributes to global Qualified PV Persons Council, wherein local and regional PV updates and best practices are exchanged and as Saudi Arabia QPPV, can maintain oversight over the PV system and the safety profiles of the marketed products.
  • Monitors and communicates in a timely manner with GPS functions about local Risk Management Plans (RMP) and risk minimization activities relevant for the territory.
  • Accountable for ensuring appropriate and accurate information in the local and central PSMF.
  • Maintains awareness of local activities such as, but not limited to, market research, patient support programs, investigator sponsored research, noninterventional studies, compassionate use programs and named patient supply.
  • Ensures awareness, review of protocols and results of postauthorization safety studies.
  • Ensures PV training and its documentation for all staff at national and regional levels as appropriate.
  • Accountable for the development, maintenance and approval of country and regional SOPs, matrices and work instructions, in accordance with global and local regulation and company practices
  • Ensures the monitoring of local and regional BeiGene sponsored websites and digital media.
  • Supports all inspectionreadiness activities; is the lead pharmacovigilance expert during inspections and audits across MENA.
  • Reviews new or updated local PV Agreements and/or Safety Data Exchange Agreements.
  • Works with business partners and vendors to ensure the maintenance of the PV system(s) across MENA.
  • Establishes appropriate back up coverage is in place and adequately trained across MENA.
  • Documents, generates, and communicates periodic and/or ad hoc data and insights pertaining to PV.
  • Identifies issues and bottlenecks in the implemented PV system(s); works to escalate and resolve issues with the aim of maintaining and improving operational excellence.
Key Relationships

  • GPS Leadership team
  • GPS Safety Science & Epidemiology (Product Safety Leads, Safety Scientists and Epidemiologists)
  • GPS Safety Operations
  • Regulatory Affairs
  • Medical Affairs
  • Quality Assurance
  • Supply Chain
Experience

  • Highly experience pharmacovigilance professional ( years minimum).
  • Highly experienced in Saudi / MENA requirements and ways of working.
  • Experience of working in small, midsize and/or large organization.
  • Highly skilled in working cross functionally.
  • Highly skilled in working independently, troubleshooting and problem solving.
  • Experience of building a PV system
  • Ability to work across regions.
  • Well connected with external industry associations in the territory.

Education Required:

  • Bachelor's degree in pharmacy or medicine.
- Master's degree a plus (e.g. -

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