Amgen Global Safety Senior Manager - China in Beijing, China
The purpose of this role is to act as the recognized safety responsible person in China, managing safety related activities within the local affiliate in line with GPS policies and procedures, local regulations and practices, and to link with other functions in the local affiliate to meet business needs. The position of Senior Safety Manager reflects wider experience, in terms of professional expertise and /or the leadership of a large/ more complex affiliate safety function.
• As part of Global Patient Safety (GPS), to be responsible for representing the local safety function on behalf of China affiliate in interactions with Regulatory agencies, Global Patient Safety (GPS) management, other functions locally, business partners, distributors, contract organisations/workers and external health care professionals, to achieve Safety objectives.
• To manage the affiliate Safety team to ensure compliant and efficient performance of safety activities in area of responsibility 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.
• To participate in exchange of safety information throughout the Amgen Global organisation to support informed understanding of product safety issues.
• The Senior Safety Manager will use wider experience and professional expertise to lead the Safety function in a large or more complex affiliate or group of affiliates or to engage in additional projects assigned.
Broader Management and Co-ordination Activities
• 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 Safety requirements
Strategic Planning Activities
• Provides affiliate input to GPS senior management planning of regional safety organisation development, capacity management, resourcing and talent management initiatives
Activities as Local Safety Responsible Person for China • 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 under responsibility and communicates new/revised information within GPS to ensure controlled documents and reporting rules are up–to-date and accurate.
• 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
• Provides safety expertise for PV discussions/meeting with local Regulators
• Provides local safety oversight /advice for agreements and interactions with business partners, distributors, functional service providers(FSP) and works with FSP assigned safety liaisons
• Collaborates locally with all relevant local stakeholders to ensure 24 hour contactability of the safety function for urgent issues is available
• Ensures that training on adverse event reporting obligations is available for local Amgen customer-facing staff and others, required by national practice or Company policy, also for relevant contractors, agents or business partners
• Participates in local Crisis Management teams; provides advice to support continuity of safety services
Management of Core Safety Affiliate Responsibilities
Manages affiliate safety staff, and confirms completion of their training, to ensure:
• Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country for inclusion in the Global Safety database
• Arranges safety review of local medical literature
• Oversees submission of all reportable adverse event reports
• Oversees the timely distribution of periodic safety reports according to local requirements
• Collaborates in the planning and dissemination of urgent safety communications, DHPCs & DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements.
• Facilitates exchange of adverse event information with functional service providers, Distributors or business partners, in line with specific agreements or procedures
• Ensures archiving of safety data, correspondence and tracking documentation according to company procedures
• Supports intake of product complaints in countries where local safety department is designated to support product quality department with product complaint intake.
• Reviews 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.
• Takes responsibility for seeking resolution of local issues that occur, through CAPAs and related activities, including facilitating those from audits or inspections.
• Ensures local quality assurance measures to support data quality and maintain inspection readiness of local safety function
• Provides local safety expertise for review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed, liaising with Medical or SOPS teams as relevant.
• Provides local Safety expertise to local stakeholders for 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
• Provides Safety resource to track dissemination of DHCPS, DILs and risk minimisation measures, such as physician education booklets.
Therapeutic Area Safety Support
• Escalates product safety issues from local Regulator or HCP bodies to Therapeutic Safety Teams and /or International Safety Management (and QP PV in European Union)
• Maintains awareness of local prescribing information(eg. SmPC), core data sheet, development core safety information, investigator brochures and risk management plans to support product safety activities, assisting with local reviews or translation of safety sections, if needed
Using expertise and, with information from Product Safety Teams:
• 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 as appropriate
• Contributes safety input to local government agency requests for data to support market access or re-imbursement applications
• Provides product safety training to commercial or medical colleagues
• 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 minimisation activities associated with approved risk management plans
• Builds awareness of product safety issues within local market or clinical research environment and feeds back to regional Safety Lead and/or line manager.
• 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
• Highly developed professional and leadership skills
• Excellent working knowledge of Amgen's policies, procedures and systems
• Deep understanding of legislation which applies to safety practices locally
• Strong understanding of local affiliate organisation and cross functional interactions.
• Excellent organisational skills
• Strong understanding of team dynamics and motivation
• Ability to develop and mentor staff effectively
• Thorough knowledge of local data privacy requirements
• Understanding of relevant medical & safety terminology
• Computer literacy with thorough knowledge of database use
Education & Experience (Basic)
Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 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)
• Professional qualification as a health care professional (doctor, pharmacist , nurse, vet ) or doctoral degree
• Experience in biotech/pharma industry, clinically based or regulatory agency role
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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