Global Safety Manager (14 Month Contract)

Amgen•Mississauga, ON

7d•CA$104,121 - CA$140,869•Hybrid

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Role: Global Safety Manager (14 Month Contract) Location: Mississauga Hybrid/Flexible Commuter What you will do Let’s do this. Let’s change the world. As part of Global Patient Safety, to support or deputise for the Safety Country Lead in representing the local safety function on behalf of their country(ies) in interactions with Regulatory agencies, GPS 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, 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.

Requirements

Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience
Experience in biotech/pharma industry, clinically based or regulatory agency role.
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

Nice To Haves

Experience with local Risk Management Plan (RMP) development and safety databases

Responsibilities

Provides support to Safety Country Lead on specific technical or operational areas
Deputises for Safety Country Lead when absent, to sustain core activities of local safety team
Works with Safety Country Lead or Regional Lead 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/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
Supervises defined technical or professional activities in maintenance of local Safety function as delegated by Safety Country Lead
Takes some activities as safety subject matter expert within the affiliate
Conducts managerial or supervisory activities for Safety staff if delegated by the Safety Country 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
Ensures that local safety activities are documented and filed or archived in line with Amgen /GPS 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
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 adverse events reported in the local country(ies) 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 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, noninterventional 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.
Maintains awareness of current prescribing information (e.g. SmPC), investigator brochures and risk management plans to support product safety activities, assisting with local reviews or translations of safety sections, if needed
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 Safety Country 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 Safety Country Lead
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor