Associate, Global Safety (14-Month Contract)

Category: Safety
Job ID: R-69467
Employment Type: Full time
Location: Canada – Mississauga
Posted Date: January 10, 2019

Role: Associate, Global Safety – 14 Month Contract

Reports to: Global Patient Safety Sr. Manager

Location: Mississauga Head Office

The purpose of this role is to conduct assigned core safety activities for the local affiliate country/countries, including safety data collection, processing and distribution, under closer supervision, whilst developing expertise in full range. To work with local safety manager to provide specific safety support activities for the local business.

This role allows for the conduct of specific core safety activities for safety including data collection, processing and distribution within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems, under closer supervision of Safety Manager. To maintain compliance with local legislation and Company policies. To assist the Safety Manager in providing the full range of safety activities to support the local business, including safety training, participation in local medical teams providing safety information.

Key Activities

Collaborative Activities:
– Participates in global/ regional /country safety meetings
– Provides input into Safety or cross functional initiatives, if required, to develop best practice

Local Safety Affiliate Activities:
– 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 /GRAAS policies and procedures
– Assists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy
– Assists local Safety team with preparations for audits and inspections of safety operations
– 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
– Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Core Safety Affiliate Responsibilities:
– Performs timely and accurate local processing steps for all adverse events reported to the local affiliate, from all sources, to enable entry into the Global Safety Database
– Assists in safety screening of local medical literature
– Timely submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports or urgent safety communications, as required by local regulations and Amgen procedures
– Facilitates exchange of adverse event information with functional service providers or business partners, in line with specific agreements or procedures
– Supports intake of product complaints, in countries where local safety is designated this activity

Compliance Activities:
– Works with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports
– Participates in resolution of local issues that occur, through CAPAs and related activities
– Ensures local quality assurance measures to maintain inspection readiness of local safety function

Therapeutic Area Safety Support:
– Escalates product safety issues to local Safety Manager
– Develops expertise in one or more product or product classes
– Maintains awareness of current prescribing information (e.g. SmPC), investigator brochures and risk management plans to support product safety activities

With support of Safety Manager and information from Therapeutic Safety Teams:
– Represents Safety in local Medical meetings to discuss product safety issues
– Provides responses to internal and externally sourced safety questions
– Provides product safety training to commercial or medical colleagues
– Assists the Safety Manager to support the local implementation of risk minimization activities associated with approved risk management plans

Basic Qualifications

BS/MS degree

Preferred Qualifications

1+ year of experience

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

Knowledge and Skills:

Evolving working knowledge of Amgen’s policies, procedures and systems
Growing understanding of legislation which applies to safety practices locally
Computer literacy with some knowledge of database use
Awareness of local data privacy requirements
Understanding of relevant medical & safety terminology
Proactive in seeking assistance in unfamiliar situations

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 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.

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