Amgen Global Safety Manager in Shanghai, China
Global Safety Manager - Affiliate (Reporting to Country Safety Lead)
Global Patient Safety & Pediatrics
The purpose of this role is to provide a management or supervisory responsibility for a sub-team or subset of activities within the local affiliate Safety, whilst reporting to the primary safety responsible person in the relevant country/countries. This Affiliate Safety Manager - Technical will show a good grasp of safety related activities within the local affiliate, demonstrating very sound understanding of GRAAS policies and procedures, local regulations and practices, deputising for country safety lead when necessary, and linking with functions in the local affiliate to meet business needs.
• As part of Global Patient Safety, to support or deputise for the country safety lead in representing the local safety function on behalf of their country(ries) in interactions with Regulatory agencies, GRAAS management, other functions locally and external health care professionals, to achieve Safety objectives.
• To supervise defined activities or sub-teams within the affiliate Safety team to ensure compliant and efficient performance of safety activities locally, based on sound knowledge of local legislative requirements and practice, GRAAS policies and procedures, with an understanding of the business needs of the local affiliate.
• To participate in exchange of safety information throughout the Amgen Global organisation to support informed understanding of product safety issues.
Broader Management and Co-ordination Activities
• Provides support to Country Safety Lead on specific technical or operational areas
• Deputises for Country Safety Lead when absent, to sustain core activities of local safety team
• Works with Country or regional Safety Leads on process
improvement initiatives or implementation of legislative changes, as required.
• Helps to plan training and development activities for local safety staff or uses technical expertise to train staff from other affiliates
• Participates in global/ regional/l /country safety meetings to share best practice on areas of technical expertise
• Provides input into cross functional programs, to reflect local requirements or operating environment
Activities as back-up Local Safety Responsible Person (For local country or countries)
• May deputise for the country safety lead, nominated to country
regulatory authority, as local safety responsible person
• Supervises defined technical or professional activities in maintenance of
local Safety function as delegated by country safety lead
• Takes some activities as safety subject matter expert within the affiliate
Local Safety Affiliate Activities (For local country or countries)
• Conducts managerial or supervisory activities for Safety staff if delegated by the Country Safety Lead or provides specialist technical expertise on defined subject areas.
• Maintains own current knowledge of and compliance with local safety regulations for local country or countries
• Works with Safety Manager to keep local affiliate safety requirements up to date in GRAAS SOPs and manuals
• Ensures that local safety activities are documented and filed or archived in line with Amgen /GRAAS policies and procedures
• Assists in training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents, business partners, or distributors
• Assists local Safety team during conduct of audits & inspections of safety operations and other PV interactions with local Regulators
• 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
Core Safety Affiliate Responsibilities
• Participates in some or all of the activities listed below according to assigned responsibilities:
• Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ries) for inclusion in the Global Safety database
• Assists in safety screening of local medical literature
• Assists with timely submission of all reportable adverse event reports
• Assists with the planning and dissemination of urgent safety communications, DHPCs and DILs required by Amgen decisions Regulatory Agency demands, according to local requirements
• Assists with the submission of periodic safety reports for local needs
• Assists exchange of adverse event information with functional service providers or business partners, in line with specific agreements or procedures
• Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity. .
According to responsibilities delegated by Country Safety Lead:
• Assists with reviews of metrics generated from Global Safety database to monitor local operating performance and reporting compliance within the affiliate Safety function, for AE case and periodic safety reports.
• Assists with resolution of local issues that occur, through CAPAs and related activities.
• Assists with maintenance of local quality assurance measures to support data quality and maintain inspection readiness of local safety function
• May assist in safety review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed.
• (In Europe - may assist QP PV in designation of local Amgen studies as PASS studies)
• May assist in local safety review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring and data collection are appropriately addressed.
• May assist in review of local Amgen sponsored websites/social media projects, if used, to ensure appropriate compliance measures are implemented, for capture of potential adverse events received
• May assist in tracking dissemination of DHCPS, DILs and risk minimisation measures, such as physician education booklets.
Therapeutic Area Safety Support:
• Assists country safety lead in escalation of product safety issues from local Regulator or HCP bodies to Therapeutic Safety Teams and /or regional Safety Management and QP PV
• Maintains awareness of current prescribing information (eg. SmPC), investigator brochures and risk management plans to support product safety activities, assisting with local reviews or translations of safety sections, if needed
Using expertise and with information from Product Safety Teams, and as delegated by Country Safety Lead:
• Represents Safety in local Medical meetings to discuss product safety issues
• Uses expertise to contribute to responses for internal and externally sourced safety questions, collaborating with Regulatory or Medical Information for delegated products or issues
• Assists Country Safety Lead with safety input to local government agency requests for data to support market access or re-imbursement applications
• Assists in tailoring of core risk management plans or periodic reports to local regulatory requirements, for specific countries not covered by regional versions.
• Provides product safety training to commercial or medical colleagues on areas of specific expertise
• Assists with the local implementation of risk minimisation activities associated with approved risk management plans
• Helps to builds awareness of product safety issues within local market or clinical research environment and feeds back to Country Safety Lead
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Knowledge and Skills
• Proven specialist expertise in areas of technical or operational activity or the ability to supervise small teams effectively
• Ability to communicate and/or train other staff effectively on specialist areas
• Problem solving 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 use
• Thorough knowledge of local data privacy requirements
• Understanding of relevant medical & safety terminology
• Excellent organisational skills
Education & Experience (Basic)
Master’s degree and 3 years of directly related experience
Bachelor’s degree an 5 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Education & Experience (Preferred)
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
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