Global Safety Manager (Saudi national only)
Saudi Arabia - Riyadh JOB ID: R-195521 LOCATION: Saudi Arabia - Riyadh WORK LOCATION TYPE: On Site DATE POSTED: Aug. 25, 2024 CATEGORY: Safety To manage the affiliate Safety team to ensure compliant and efficient performance of safety activities locally, based on sound knowledge of local legislative requirements and practice, GPS policies and procedures, with an understanding of the business needs of the local affiliate. Provides leadership to local safety team, setting goals and operational guidance in line with GPS objectives Manages local staff and budget resources Works with Regional safety leads on process improvement initiatives or implementation of legislative changes Guides training and development activities for local safety staff Participates in global/ regional /country safety meetings to share best practice Provides input into cross functional programs, to reflect local requirements Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Is nominated to country regulatory authority as local safety responsible person Acts as safety subject matter expert within the affiliate Maintains own current knowledge of and compliance with local safety regulations for country or countries under responsibility Communicates requirements and updates to Safety BPOs and line manager, and ensures local affiliates safety requirements are up to date in GPS SOPs and manuals Ensures that local safety procedures are documented in line with Amgen Collaborates locally with all relevant stakeholders to ensure 24 hour contact ability of the safety function for urgent issues is available Works with local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable Ensures that training on adverse reporting obligations is available for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents or business partners or distributors Participates in local Crisis Management teams; provides ongoing safety advice Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Timely & accurate capture, routing, , translation, and follow up of all adverse events reported to the local country(ies), , for inclusion in the Global Safety Database Arranges safety review of local medical literature Oversees submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports, as required by local regulations and Amgen procedures. Collaborates in the planning and dissemination of urgent safety communications, DHPCs & DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements. Assists in tailoring of core risk management plans or periodic reports to local regulatory requirements, for specific countries not covered by regional versions. Supports the local implementation of risk minimization activities associated with approved risk management plans Facilitates exchange of adverse event information with functional service providers or business partners, or distributors, in line with specific agreements or procedures Takes responsibility for seeking resolution of local issues that occur, through CAPAs and related activities. Ensures local quality assurance measures to support data quality and maintain inspection readiness of local safety function.Knowledge and Skills: Excellent working knowledge of Amgen's policies, procedures and systems Deep understanding of legislation which applies to safety practices locally Computer literacy with thorough knowledge of database useThorough knowledge of local data privacy requirements Understanding of relevant medical & safety terminology Excellent organizational skillsEducation & Experience (Basic): Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience. Education & Experience (Preferred): * Experience in biotech/pharma industry, clinically based or regulatory agency role.
