Career Category

Job Description

Title: Global Safety Manager

Reports to: Country Safety Lead

Location: Mississauga Head Office

Job Summary

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Summary:

- representing the local safety function in interactions with Regulatory agencies, GRAAS management, other functions locally and external health care professionals, to achieve Safety objectives.
• 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.

Key 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
 

Local Safety Affiliate Activities
• 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. .

Compliance Management:
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.
• 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

Basic Qualifications

BSc degree

5+ years of related experience

Knowledge & 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview.