Career Category

Job Description

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 (For local country or countries)
- 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 & 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 & 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 minimisation activities associated with approved risk management plans