Global Safety Manager

Career Category

Safety

Job Description

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.

Key Responsibilities:

Broader Management and Co-ordination Activities:

• 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

Activities as back-up Local Safety Responsible Person (For local country):

• 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

Local Safety Affiliate Activities (For local country):

• 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

Core Safety Affiliate Responsibilities:

• Participates in some or all the activities listed below according to assigned responsibilities:
• 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

Compliance Management:

• 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.

Therapeutic Area Safety Support:

• 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

Using expertise and with information from Product Safety Teams, and as delegated by Safety Country 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 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a candidate with these qualifications.

Basic Qualifications:

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.

Preferred Qualifications:

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

Amgen is proud to have been recognized as one of LinkedIn Top 25 Companies in Canada for career growth. Click HERE for more details. 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.

The salary range for this position in Canada is $104,121 - $140,869

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation

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Salary Range

104,120.75 CAD - 140,869.25 CAD